Weight GainPRECODENCT04694235
Egg Intervention During Pregnancy in Indonesia
A study testing Egg intervention in people with Weight Gain and Anemia, Iron Deficiency, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
Trial summary
The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Anemia, Iron Deficiency, Birth Weight
- What is being tested?
- Egg intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Feb 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman is between 16 and 20 weeks of pregnancy based on the date of the first day of her last menstrual period.
- She is 18-40 years of age.
- She is planning to remain in the study area over the next 30 months.
- She is of Sasak ethnicity
Who cannot join
- She is expecting multiple births.
- She has a known egg allergy.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Aikmel, Sakra, and Sikur Subdistrict
Mataram, West Nusa Tenggara
About this study
Official title: Effect on Pregnancy Outcomes, Infant Growth and Development of an Egg Intervention During Pregnancy in Indonesia
The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old
Read the detailed description
The study aims to assess the impact of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes in infants. The open-label intervention study would be conducted alongside the observational study in the same study setting by recruitment of additional number (n=153) of pregnant women. Thus, a total of 653 pregnant women would be enrolled in the study; 153 women would be randomized to intervention arm and 500 to the control arm who would form an observational cohort of women and newborns as described above. The intervention group women will be provided one egg three times per week from recruitment (2nd trimester) until term. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives or Public Health Centre (IFA tablet, calcium tablet, nutrition counselling).
- Conditions
- Weight Gain, Anemia, Iron Deficiency, Birth Weight, Birth Length, Child Development, Zinc Deficiency
- Being tested
- Egg intervention
- Keywords
- Egg, Pregnancy, Indonesia, Epigenetic, Growth, Child development
- Medical subject headings
- Weight Gain, Anemia, Iron-Deficiency, Birth Weight, Folic Acid Deficiency, Vitamin B 12 Deficiency, Vitamin A Deficiency, Parasitic Diseases, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg interventionDietary supplement
Eggs are boiled until the white and yolk are firm (ca. 8 minutes) to maintain quality and safety and ensure the eggs are safe for consumption.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort (control group) | No intervention | In the observational cohort, pregnant mothers in the 2nd trimester (n=500) will be recruited and they will be followed up until their children are 24 months old. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives (Polindes) or Puskesmas (IFA tablet, calcium tablet, nutrition counselling). |
| Intervention group | Experimental | The intervention group women (n=153) will be provided one egg three times per week from recruitment (2nd trimester) until term along with the standard Ante Natal Care. Receives: Dietary Supplement: Egg intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of stunting
Z-score of LAZ <-2 SD based on WHO 2006
Measured: birth until 24 months after delivery
Proportion of children 10-14 months with impaired fine and gross motor skills
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess fine and gross motor skills among children aged 10 to 14 months
Measured: 10-14 months of age
Proportion of children 10-14 months with impaired expressive and receptive language
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess expressive and receptive language among children aged 10 to 14 months
Measured: 10-14 months of age
Proportion of children 10-14 months with impaired behavior
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess behavior among children aged 10 to 14 months
Measured: 10-14 months of age
Proportion of children 10-14 months with impaired executive function
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess executive function among children aged 10 to 14 months
Measured: 10-14 months of age
Proportion of children 10-14 months with impaired empathy
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess empathy among children aged 10 to 14 months
Measured: 10-14 months of age
Proportion of children 10-14 months with impaired problem solving
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess problem solving among children aged 10 to 14 months
Measured: 10-14 months of age
Proportion of children 10-14 months with impaired attention
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess attention among children aged 10 to 14 months
Measured: 10-14 months of age
Proportion of children 10-14 months with impaired social-emotional reactivity
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess social-emotional reactivity among children aged 10 to 14 months
Measured: 10-14 months of age
Proportion of children 20-24 months with impaired motor development
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess motor development among children aged 20 to 24 months
Measured: 20-24 months of age
Proportion of children 20-24 months with impaired cognition
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess cognition among children aged 20 to 24 months
Measured: 20-24 months of age
Proportion of children 20-24 months with impaired language
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess language among children aged 20 to 24 months
Measured: 20-24 months of age
Proportion of children 20-24 months with impaired social-emotional development
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess social-emotional development among children aged 20 to 24 months
Measured: 20-24 months of age
Scores of CDI vocabulary comprehension scale in children 10-12 months
MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary comprehension scale among children aged 10 to 12 months
Measured: 10-12 months of age
Scores of CDI vocabulary production scale in children 10-12 months
MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary production among children aged 10 to 12 months
Measured: 10-12 months of age
Epigenetic state of genes associated with stunting
Genome-wide analysis of epigenetic states using the Illumina Infinium Methylation EPIC 850k Bead Chip (EPIC array) will be performed for selected samples from the core cohort. The outcomes will be the epigenetic state of a large number of genes which are associated with child stunting.
Measured: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
Epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability
All samples (newborn, children 24 mo, parents) will be analyzed using Next Generation Bisulphite Amplicon Sequencing (BSAS) from Illumina MiSeq platform in targeted regions of the genome. The outcomes will be profiles of specific epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability.
Measured: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
Secondary outcomes (31)
Weight gain during pregnancy
All measurements will be taken to the nearest 0.1 kg using standard procedures with SECA weighing machine.
Measured: 2nd trimester (16-20 weeks gestation) and 3rd trimester (28-32 weeks gestation) of pregnancy
Birth weight
All measurements will be taken to the nearest 0.1 kg using standard procedures with SECA weighing machine.
Measured: 24 hours after birth
Birth length
All measurements will be taken to the nearest milimeter using standard procedures with SECA stadiometer/infantometer.
Measured: 24 hours after birth
Hemoglobin concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their hemoglobin.
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum ferritin concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum ferritin
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum transferrin receptor concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum transferrin receptor
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum zinc concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum zinc
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum retinol concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum retinol
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
RBC folate concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their RBC folate
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum vitamin B12 concentration
Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B12
Measured: Mothers: second and third trimester of pregnancy
RBC fatty acids concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their RBC fatty acids
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum essential amino acids concentration
Nutritional status measured by biochemical assessment to the mothers for their serum essential amino acids
Measured: Mothers: second and third trimester of pregnancy
Serum methylmalonic acid concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum methylmalonic acid
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum choline concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum choline
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum betaine concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum betaine
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum vitamin B2 concentration
Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B2
Measured: Mothers: second and third trimester of pregnancy
Serum vitamin B6 concentration
Nutritional status measured by biochemical assessment to the mothers for their serum vitamin B6
Measured: Mothers: second and third trimester of pregnancy
Serum vitamin D concentration
Nutritional status measured by biochemical assessment to the mothers for their serum vitamin D
Measured: Mothers: second and third trimester of pregnancy
Serum CRP concentration
Subclinical inflammation will be measured by serum CRP in pregnant mothers and children
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum AGP concentration
Subclinical inflammation will be measured by serum AGP in pregnant mothers and children
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum RBP concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum RBP
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum hepcidine concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum hepcidine
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum homocysteine concentration
Nutritional status measured by biochemical assessment to the mothers and children. Both the pregnant mothers and children will be measured for their serum homocysteine
Measured: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum HbA1C concentration
Gestational diabetes status will be assesed to the mothers for their serum HbA1C
Measured: Mothers: second and third trimester of pregnancy
Fecal myeloperoxidase (MPO)
Gut inflammation from fecal will be measured by faecal myeloperoxidase (MPO) using ELISA
Measured: baby: 1, 6, 24 months of age
Fecal α1-antitrypsin (AAT)
Gut inflammation from fecal will be measured by fecal α1-antitrypsin (AAT) using ELISA
Measured: baby: 1, 6, 24 months of age
Soil-transmitted helminths infection
Fecal parasites from fecal will be assesed by Kato Katz and confirmed by qPCR
Measured: mothers: 3rd trimester (28-32 gestational weeks) of pregnancy; baby: 1, 6, 24 months of age
Bacteria infection
Type of bacteria (Salmonella, Shigella) from fecal will be assesed by culture method
Measured: baby: 1, 6, 24 months of age
Gut microbiota
Gut microbiota species (EPEC, ETEC, EHEC, EIEC) from fecal will be assesed using qPCR
Measured: baby: 1, 6, 24 months of age
Gut microbiome
Faecal microbiome would be analyzed using 16S RNA sequencing of the V4 region on the Illumina MiSeq and BSAS.
Measured: baby: 1, 6, 24 months of age
Intestinal fatty acid binding protein
Intestinal fatty acid binding protein from serum will be measured using ELISA
Measured: baby: 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start12 Feb 2021
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 653 pregnant women will be recruited from 40 villages in three sub-districts. Pregnant women will be randomly allocated into the intervention or control groups. Pregnant women in the intervention group will receive boiled eggs three times per week from 2nd trimester (16-20 weeks) until delivery.
- Masking
- None (open label)
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEAMEO Regional Centre for Food and Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Aberdeen, University of Brighton, University College, London, Royal Veterinary College, Birkbeck, University of London, The International Livestock Research Institute (ILRI), Cheikh Anta Diop University, Senegal, National Institute of Nutrition, India, International Centre for Research in Agroforestry, Science Made Simple, Liverpool School of Tropical Medicine, International Initiative for Impact Evaluation, Digital Green Foundation, SOAS, University of London, University of Sheffield
- Responsible party
- Principal investigator, Dr.Umi Fahmida, SEAMEO Regional Centre for Food and Nutrition
- Investigators
- Umi Fahmida, Dr., Principal investigator, SEAMEO RECFON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694235
- Sponsor's protocol ID
- AASH Egg intervention
- Acronym
- PRECODE
- Status last verified
- Jul 2024
- First submitted
- 22 Dec 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boeke CE, Gillman MW, Hughes MD, Rifas-Shiman SL, Villamor E, Oken E. Choline intake during pregnancy and child cognition at age 7 years. Am J Epidemiol. 2013 Jun 15;177(12):1338-47. doi: 10.1093/aje/kws395. Epub 2013 Feb 20.
PubMed 23425631Caudill MA, Strupp BJ, Muscalu L, Nevins JEH, Canfield RL. Maternal choline supplementation during the third trimester of pregnancy improves infant information processing speed: a randomized, double-blind, controlled feeding study. FASEB J. 2018 Apr;32(4):2172-2180. doi: 10.1096/fj.201700692RR. Epub 2018 Jan 5.
PubMed 29217669Clare CE, Brassington AH, Kwong WY, Sinclair KD. One-Carbon Metabolism: Linking Nutritional Biochemistry to Epigenetic Programming of Long-Term Development. Annu Rev Anim Biosci. 2019 Feb 15;7:263-287. doi: 10.1146/annurev-animal-020518-115206. Epub 2018 Nov 9.
PubMed 30412672Haggarty P. Epigenetic consequences of a changing human diet. Proc Nutr Soc. 2013 Nov;72(4):363-71. doi: 10.1017/S0029665113003376. Epub 2013 Sep 13.
PubMed 24028891Haggarty P, Hoad G, Campbell DM, Horgan GW, Piyathilake C, McNeill G. Folate in pregnancy and imprinted gene and repeat element methylation in the offspring. Am J Clin Nutr. 2013 Jan;97(1):94-9. doi: 10.3945/ajcn.112.042572. Epub 2012 Nov 14.
PubMed 23151531Whitelaw N, Bhattacharya S, Hoad G, Horgan GW, Hamilton M, Haggarty P. Epigenetic status in the offspring of spontaneous and assisted conception. Hum Reprod. 2014 Jul;29(7):1452-8. doi: 10.1093/humrep/deu094. Epub 2014 May 8.
PubMed 24812310Lorgen-Ritchie M, Murray AD, Ferguson-Smith AC, Richards M, Horgan GW, Phillips LH, Hoad G, Gall I, Harrison K, McNeill G, Ito M, Haggarty P. Imprinting methylation in SNRPN and MEST1 in adult blood predicts cognitive ability. PLoS One. 2019 Feb 1;14(2):e0211799. doi: 10.1371/journal.pone.0211799. eCollection 2019.
PubMed 30707743Masser DR, Stanford DR, Freeman WM. Targeted DNA methylation analysis by next-generation sequencing. J Vis Exp. 2015 Feb 24;(96):52488. doi: 10.3791/52488.
PubMed 25741966Dighe MK, Frederick IO, Andersen HF, Gravett MG, Abbott SE, Carter AA, Algren H, Rocco DA, Waller SA, Sorensen TK, Enquobahrie D, Blakey I, Knight HE, Cheikh Ismail L; International Fetal and Newborn Growth Consortium for the 21st Century. Implementation of the INTERGROWTH-21st Project in the United States. BJOG. 2013 Sep;120(Suppl 2):123-8, v. doi: 10.1111/1471-0528.12126. Epub 2013 Jul 11.
PubMed 23841827Weisenberger D, Van Den Berg D, Pan F, Berman B, Laird P. Comprehensive DNA methylation analysis on the Illumina Infinium assay platform. Illumina, San Diego. 2008.
Fenson L, Pethick S, Renda C, Cox JL, Dale PS, Reznick JS. Short-form versions of the MacArthur communicative development inventories. Applied Psycholinguistics. 2000;21(1):95-116.
Zeisel SH, Mar MH, Howe JC, Holden JM. Concentrations of choline-containing compounds and betaine in common foods. J Nutr. 2003 May;133(5):1302-7. doi: 10.1093/jn/133.5.1302.
PubMed 12730414Patterson KY, Bhagwat SA, Williams JR, Howe JC, Holden J, Zeisel S, et al. USDA database for the choline content of common foods, release two. Nutrient Data Laboratory, Beltsville Human Nutrition Research Center, ARS, USDA. 2008.
Cho E, Zeisel SH, Jacques P, Selhub J, Dougherty L, Colditz GA, Willett WC. Dietary choline and betaine assessed by food-frequency questionnaire in relation to plasma total homocysteine concentration in the Framingham Offspring Study. Am J Clin Nutr. 2006 Apr;83(4):905-11. doi: 10.1093/ajcn/83.4.905.
PubMed 16600945Mhila G, DeRenzi B, Mushi C, Wakabi T, Steele M, Dhaldialla P, et al. Using mobile applications for community-based social support for chronic patients. Health Informatics in Africa. 2009.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Pregnancy Outcomes, Infant Growth and Development of an Egg Intervention During Pregnancy in Indonesia
- ClinicalTrials.gov ID
- NCT04694235
- Acronym / sponsor ID
- PRECODE / AASH Egg intervention
- Conditions
- Weight Gain, Anemia, Iron Deficiency, Birth Weight, Birth Length, Child Development, Zinc Deficiency
- Keywords
- Egg, Pregnancy, Indonesia, Epigenetic, Growth, Child development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 702 participants (actual)
- Lead sponsor
- SEAMEO Regional Centre for Food and NutritionUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Aberdeen, University of Brighton, University College, London, Royal Veterinary College, Birkbeck, University of London, The International Livestock Research Institute (ILRI), Cheikh Anta Diop University, Senegal, National Institute of Nutrition, India, International Centre for Research in Agroforestry, Science Made Simple, Liverpool School of Tropical Medicine, International Initiative for Impact Evaluation, Digital Green Foundation, SOAS, University of London, University of Sheffield
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old
Detailed description
The study aims to assess the impact of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes in infants. The open-label intervention study would be conducted alongside the observational study in the same study setting by recruitment of additional number (n=153) of pregnant women. Thus, a total of 653 pregnant women would be enrolled in the study; 153 women would be randomized to intervention arm and 500 to the control arm who would form an observational cohort of women and newborns as described above. The intervention group women will be provided one egg three times per week from recruitment (2nd trimester) until term. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives or Public Health Centre (IFA tablet, calcium tablet, nutrition counselling).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 653 pregnant women will be recruited from 40 villages in three sub-districts. Pregnant women will be randomly allocated into the intervention or control groups. Pregnant women in the intervention group will receive boiled eggs three times per week from 2nd trimester (16-20 weeks) until delivery.
| Arm | Type | Receives |
|---|---|---|
| Observational cohort (control group) | No intervention | –In the observational cohort, pregnant mothers in the 2nd trimester (n=500) will be recruited and they will be followed up until their children are 24 months old. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives (Polindes) or Puskesmas (IFA tablet, calcium tablet, nutrition counselling). |
| Intervention group | Experimental | Dietary Supplement: Egg interventionThe intervention group women (n=153) will be provided one egg three times per week from recruitment (2nd trimester) until term along with the standard Ante Natal Care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Woman is between 16 and 20 weeks of pregnancy based on the date of the first day of her last menstrual period.
- She is 18-40 years of age.
- She is planning to remain in the study area over the next 30 months.
- She is of Sasak ethnicity
Key exclusion criteria (2 listed)
- She is expecting multiple births.
- She has a known egg allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg interventionEggs are boiled until the white and yolk are firm (ca. 8 minutes) to maintain quality and safety and ensure the eggs are safe for consumption. | Dietary supplement | Intervention group |
Primary outcome
Prevalence of stunting
Time frame: birth until 24 months after delivery
Z-score of LAZ <-2 SD based on WHO 2006
Proportion of children 10-14 months with impaired fine and gross motor skills
Time frame: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess fine and gross motor skills among children aged 10 to 14 months
Proportion of children 10-14 months with impaired expressive and receptive language
Time frame: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess expressive and receptive language among children aged 10 to 14 months
Proportion of children 10-14 months with impaired behavior
Time frame: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess behavior among children aged 10 to 14 months
Proportion of children 10-14 months with impaired executive function
Time frame: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess executive function among children aged 10 to 14 months
Proportion of children 10-14 months with impaired empathy
Time frame: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess empathy among children aged 10 to 14 months
Proportion of children 10-14 months with impaired problem solving
Time frame: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess problem solving among children aged 10 to 14 months
Proportion of children 10-14 months with impaired attention
Time frame: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess attention among children aged 10 to 14 months
Proportion of children 10-14 months with impaired social-emotional reactivity
Time frame: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess social-emotional reactivity among children aged 10 to 14 months
Proportion of children 20-24 months with impaired motor development
Time frame: 20-24 months of age
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess motor development among children aged 20 to 24 months
Proportion of children 20-24 months with impaired cognition
Time frame: 20-24 months of age
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess cognition among children aged 20 to 24 months
Proportion of children 20-24 months with impaired language
Time frame: 20-24 months of age
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess language among children aged 20 to 24 months
Proportion of children 20-24 months with impaired social-emotional development
Time frame: 20-24 months of age
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess social-emotional development among children aged 20 to 24 months
Scores of CDI vocabulary comprehension scale in children 10-12 months
Time frame: 10-12 months of age
MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary comprehension scale among children aged 10 to 12 months
Scores of CDI vocabulary production scale in children 10-12 months
Time frame: 10-12 months of age
MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary production among children aged 10 to 12 months
Epigenetic state of genes associated with stunting
Time frame: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
Genome-wide analysis of epigenetic states using the Illumina Infinium Methylation EPIC 850k Bead Chip (EPIC array) will be performed for selected samples from the core cohort. The outcomes will be the epigenetic state of a large number of genes which are associated with child stunting.
Epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability
Time frame: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
All samples (newborn, children 24 mo, parents) will be analyzed using Next Generation Bisulphite Amplicon Sequencing (BSAS) from Illumina MiSeq platform in targeted regions of the genome. The outcomes will be profiles of specific epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability.
31 secondary outcomes
Weight gain during pregnancy
Time frame: 2nd trimester (16-20 weeks gestation) and 3rd trimester (28-32 weeks gestation) of pregnancy
Birth weight
Time frame: 24 hours after birth
Birth length
Time frame: 24 hours after birth
Hemoglobin concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum ferritin concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum transferrin receptor concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum zinc concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum retinol concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
RBC folate concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum vitamin B12 concentration
Time frame: Mothers: second and third trimester of pregnancy
RBC fatty acids concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum essential amino acids concentration
Time frame: Mothers: second and third trimester of pregnancy
Serum methylmalonic acid concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum choline concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum betaine concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum vitamin B2 concentration
Time frame: Mothers: second and third trimester of pregnancy
Serum vitamin B6 concentration
Time frame: Mothers: second and third trimester of pregnancy
Serum vitamin D concentration
Time frame: Mothers: second and third trimester of pregnancy
Serum CRP concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum AGP concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum RBP concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum hepcidine concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum homocysteine concentration
Time frame: Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery
Serum HbA1C concentration
Time frame: Mothers: second and third trimester of pregnancy
Fecal myeloperoxidase (MPO)
Time frame: baby: 1, 6, 24 months of age
Fecal α1-antitrypsin (AAT)
Time frame: baby: 1, 6, 24 months of age
Soil-transmitted helminths infection
Time frame: mothers: 3rd trimester (28-32 gestational weeks) of pregnancy; baby: 1, 6, 24 months of age
Bacteria infection
Time frame: baby: 1, 6, 24 months of age
Gut microbiota
Time frame: baby: 1, 6, 24 months of age
Gut microbiome
Time frame: baby: 1, 6, 24 months of age
Intestinal fatty acid binding protein
Time frame: baby: 6 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 23425631Boeke CE, Gillman MW, Hughes MD, Rifas-Shiman SL, Villamor E, Oken E. Choline intake during pregnancy and child cognition at age 7 years. Am J Epidemiol. 2013 Jun 15;177(12):1338-47. doi: 10.1093/aje/kws395. Epub 2013 Feb 20.
- Background: PubMed 29217669Caudill MA, Strupp BJ, Muscalu L, Nevins JEH, Canfield RL. Maternal choline supplementation during the third trimester of pregnancy improves infant information processing speed: a randomized, double-blind, controlled feeding study. FASEB J. 2018 Apr;32(4):2172-2180. doi: 10.1096/fj.201700692RR. Epub 2018 Jan 5.
- Background: PubMed 30412672Clare CE, Brassington AH, Kwong WY, Sinclair KD. One-Carbon Metabolism: Linking Nutritional Biochemistry to Epigenetic Programming of Long-Term Development. Annu Rev Anim Biosci. 2019 Feb 15;7:263-287. doi: 10.1146/annurev-animal-020518-115206. Epub 2018 Nov 9.
- Background: PubMed 24028891Haggarty P. Epigenetic consequences of a changing human diet. Proc Nutr Soc. 2013 Nov;72(4):363-71. doi: 10.1017/S0029665113003376. Epub 2013 Sep 13.
- Background: PubMed 23151531Haggarty P, Hoad G, Campbell DM, Horgan GW, Piyathilake C, McNeill G. Folate in pregnancy and imprinted gene and repeat element methylation in the offspring. Am J Clin Nutr. 2013 Jan;97(1):94-9. doi: 10.3945/ajcn.112.042572. Epub 2012 Nov 14.
- Background: PubMed 24812310Whitelaw N, Bhattacharya S, Hoad G, Horgan GW, Hamilton M, Haggarty P. Epigenetic status in the offspring of spontaneous and assisted conception. Hum Reprod. 2014 Jul;29(7):1452-8. doi: 10.1093/humrep/deu094. Epub 2014 May 8.
- Background: PubMed 30707743Lorgen-Ritchie M, Murray AD, Ferguson-Smith AC, Richards M, Horgan GW, Phillips LH, Hoad G, Gall I, Harrison K, McNeill G, Ito M, Haggarty P. Imprinting methylation in SNRPN and MEST1 in adult blood predicts cognitive ability. PLoS One. 2019 Feb 1;14(2):e0211799. doi: 10.1371/journal.pone.0211799. eCollection 2019.
- Background: PubMed 25741966Masser DR, Stanford DR, Freeman WM. Targeted DNA methylation analysis by next-generation sequencing. J Vis Exp. 2015 Feb 24;(96):52488. doi: 10.3791/52488.
- Background: PubMed 23841827Dighe MK, Frederick IO, Andersen HF, Gravett MG, Abbott SE, Carter AA, Algren H, Rocco DA, Waller SA, Sorensen TK, Enquobahrie D, Blakey I, Knight HE, Cheikh Ismail L; International Fetal and Newborn Growth Consortium for the 21st Century. Implementation of the INTERGROWTH-21st Project in the United States. BJOG. 2013 Sep;120(Suppl 2):123-8, v. doi: 10.1111/1471-0528.12126. Epub 2013 Jul 11.
- BackgroundWeisenberger D, Van Den Berg D, Pan F, Berman B, Laird P. Comprehensive DNA methylation analysis on the Illumina Infinium assay platform. Illumina, San Diego. 2008.
- BackgroundFenson L, Pethick S, Renda C, Cox JL, Dale PS, Reznick JS. Short-form versions of the MacArthur communicative development inventories. Applied Psycholinguistics. 2000;21(1):95-116.
- Background: PubMed 12730414Zeisel SH, Mar MH, Howe JC, Holden JM. Concentrations of choline-containing compounds and betaine in common foods. J Nutr. 2003 May;133(5):1302-7. doi: 10.1093/jn/133.5.1302.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umi Fahmida, Dr. principal investigator
SEAMEO RECFON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg intervention in people with Weight Gain and Anemia, Iron Deficiency, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of stunting (time frame: birth until 24 months after delivery). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694235, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.