Folate DeficiencyNCT06100146
Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls
A study testing Folic acid and vitamin B12 fortified flour and Unfortified cereal flour in people with Folate Deficiency and Vitamin B 12 Deficiency, run by University Ghent at 2 sites in Ethiopia.
Trial summary
Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. A deficiency of either vitamin will predispose teenagers to many diseases, which persist across their lifespan. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Folate Deficiency, Vitamin B 12 Deficiency, Anemia, Megaloblastic
- What is being tested?
- Folic acid and vitamin B12 fortified flour and Unfortified cereal flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 2 sitesEthiopia
- Study dates
- 11 Dec 2023to 31 Aug 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 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Teenage girls between 13 and 19 years of age who live in households at Arba Minch Health and Demographic Surveillance Sites (AM-HDSS) are eligible to participate in the study if:
- One or both of their parents signed an informed consent form and the girl's agreement.
- Their parents and the girl planned to stay in the study area during the period of the study (minimum 6 months) in the kebele.
- Both parents and girls accept the intervention packages including blood draws and home visits.
Who cannot join
- Chronically ill girls diagnosed with diabetes and asthma;
- Severely undernourished girls (defined as body mass index z score < -3 standard deviations of the median World Health Organization reference population);
- Severely anaemic girls (Hb concentration <80g/L);
- Teenage girls who are pregnant, lactating or taking IFA/B12 supplements;
- Diagnosed hemoglobinopathy (sickle cell or thalassemia);
- Diagnosed liver diseases like acute hepatitis, cirrhosis, hepatocellular carcinoma, and metastatic liver disease
Trial locations and contacts
2 sites in 1 country.
Ethiopia2 sites
Arba Minch Health and Demographic Surveillance System sites
Arba Minch, 21
Arba Minch University
Arba Minch
About this study
Official title: Does Small Scale Cereal-based Fortification Hold the Key to Improved Micronutrient Status in Ethiopia? The Case of Folic Acid and Vitamin B12 in Teenage Girls in Arba Minch, Ethiopia
Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. A deficiency of either vitamin will predispose teenagers to many diseases, which persist across their lifespan. Fortification of food with micronutrients has been promoted to reduce micronutrient deficiencies. A large segment of vulnerable populations in low- and middle-income countries (LMICs) resides in rural settings and has limited access to large-scale commercialized fortified foods. In such operational constraints, the use of locally (small-scale) fortified cereals could be an alternative intervention. The study aims to evaluate the effectiveness of small scale folic acid and vitamin B12 fortified cereals in improving folate and vitamin B12 status, growth velocity, puberty status, anaemia, cognitive development and mental health among teenage girls, in rural rift valley of Ethiopia.
Read the detailed description
Folic acid (FA) and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. Teenagers are the future mothers. Hence their health and nutritional status have long term consequences on future pregnancies and birth outcomes. Neural Tube Defects (NTDs) are a group of fatal or severely disabling birth defects known to be mainly a consequence of severe folate deficiency in early pregnancy. The policy of advising women to take iron \& FA (IFA) supplements during pregnancy has not been successful in preventing NTDs because of the low adherence to antenatal care services including IFA, the large proportion of unplanned pregnancies, the timing at which IFA supplementation starts, and the logistical limitation that makes the access to IFA limited. The evidence is strong on the importance of food fortification in the promotion of maternal and child health mainly through reducing micronutrient deficiencies. A large segment of vulnerable populations in developing countries resides in rural settings and has limited access to fortified foods in the market. In such operational constraints, using locally fortified cereals could be an alternative intervention. However, there is a paucity of evidence regarding effectiveness of small-scale cereal-based fortification; in Ethiopia, the evidence is inexistent. Moreover, teenage girls are an under-studied group and do not constitute a target population from different nutritional intervention programs.
The overall objective of this study is to evaluate the effectiveness of small-scale folic acid and vitamin B12-fortified cereals in improving folate and vitamin B12 status, growth velocity, puberty status, anaemia, cognitive development and mental health among rural teenage girls (13-19 years of age).
This study will be conducted in Arba Minch Health and Demographic Surveillance Sites (AM-HDSS), Southern Ethiopia from October 2023 to April 2024. Effectiveness of intake of folic acid and vitamin B12 fortified meals will be evaluated in a randomized, double-blind controlled trial among 474 teenage girls between 13 and 19 years of age who are residing in and attending one of the schools at AM-HDSS.
Data on the following variables, except for demographic characteristics of teenage girls and their respective parents and/or household heads will be collected at the start and end point of the 6 months intervention. Data collection will be carried out at schools and at respective girls' home.
- Demographic characteristics of the teenage girls, morbidity status, helminthic infections, dietary intake, anthropometry, puberty status, presence of depressive symptoms, biochemical samples and cognitive development will be assessed in teenage girls directly at schools.
- Socio-demographic characteristics of the parents or the head of the household if different from parents, family wealth status, food security, health care services and environmental characteristics will be collected in recruited teenage girls' households within the one week following the enrolment and at the end of the intervention.
- Conditions
- Folate Deficiency, Vitamin B 12 Deficiency, Anemia, Megaloblastic, Cognitive Development, Depressive Symptoms
- Being tested
- Folic acid and vitamin B12 fortified flour, Unfortified cereal flour
- Keywords
- Small scale fortification, Folic acid, Vitamin B12, Anemia, Cognitive development, Teenage girls
- Medical subject headings
- Folic Acid Deficiency, Vitamin B 12 Deficiency, Anemia, Megaloblastic, Depression, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acid and vitamin B12 fortified flourDietary supplement
Also called Intervention group
Standard bags of fortified cereal-based flours will be prepared at local mills from the common staple cereal food in the area. The dose of vitamins will be added to the flour of the intervention group and mixed with batch mixing technique. The concentration of folic acid and vitamin B12 per 1kg of flour will be 2mg and 0.02mg, respectively. Participants will be supplied with 6 kg bags of flour, which will be enough for 30 days, and 1.5kg bags of flour will be delivered to their home on a weekly basis and lasting for 6 months. Instructions on the preparation of meals and frequency of intake with a weekly compliance sheet will be provided for monitoring the intervention.
Unfortified cereal flourOther
Also called Control group
Standard bags of unfortified cereal-based flours will be prepared at local mills from the common staple cereal food in the area. Participants will be supplied with 6 kg bags of flour, which will be enough for 30 days, and 1.5kg bags of flour will be delivered to their home on a weekly basis and lasting for 6 months. Instructions on the preparation of meals and frequency of intake with a weekly compliance sheet will be provided for monitoring the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Teenage girls randomly assigned to the control group will receive a standard bag of unfortified cereal flours every week for six months. Receives: Other: Unfortified cereal flour |
| folic acid & vit B12 fortified flour | Experimental | Teenage girls randomly assigned to the control group will receive a standard bag of cereal flours fortified with folic acid and Vit B12 every week for six months. Receives: Dietary Supplement: Folic acid and vitamin B12 fortified flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum folic acid concentrations
Serum folate levels ng/ml (nmol/l)
Measured: Assessed at 6 months
Erythrocyte (RBC) folic acid concentrations
RBC folate level ng/ml (nmol/l)
Measured: Assessed at 6 months
General cognitive ability
Raven Progressive Matrices (RPM) tests, a measure of nonverbal intelligence.
Measured: Assessed at 6 months
Working memory
Digit Span (Forward, Backward, and Sequencing) is a standardized test that assesses the working memory of participants.
Measured: Assessed at 6 months
Depression
Depressive symptoms will be assessed by Patient Health Questionnaire (PHQ) 9 modified for adolescents (PHQ-9A), a self-report instrument comprised of 9-items. Items are rated on a four-point ordinal scale.
Measured: Assessed at 6 months
Serum vitamin B12 concentrations
Serum vitamin B12 level (pmol/L)
Measured: Assessed at 6 months
Fat-free mass
An index of adiposity will be measured to evaluate girls' body composition, in %
Measured: Assessed at 6 months
Fat mass
An index of adiposity will be measured to evaluate girls' body composition, in kg
Measured: Assessed at 6 months
Secondary outcomes (9)
RBC structure (megaloblastic anaemia)
Mean Corpuscular Volume (MCV) in femtoliters/fl
Measured: Assessed at 6 months
Plasma homocysteine concentrations
Plasma homocysteine level (µmol/L)
Measured: Assessed at 6 months
Weight
Participant weight (kg)
Measured: Assessed at 3 and 6 months
Adherence to the intervention/fortification
adherence to the flour consumption will be assessed through home to home visit in a weekly basis.
Measured: Assessed weekly for the whole period of intervention (until 6 months)
Haemoglobin concentration
Haemoglobin concentration (g/dl)
Measured: Assessed at 6 months
Height
Participant height (cm)
Measured: Assessed at 6 months
Puberty status
The pubertal status will be assessed by Pubertal Development Scale which has a 4-point scale ranging from 1 (has not begun) to 4 (development completed). Girls will report on their body hair development, growth spurt, skin changes, breast development and the occurrence of menarche (1=no and 4=yes).
Measured: Assessed at 6 months of fortification
Prevalence of soil-transmitted helminths
The presence of worm parasites and egg density in the stools. Three common parasites and their eggs will be investigated, i.e. Ascaris lumbricoides (round worm), Trichuris trichiura (whipworm) and Ancyclostoma duodenale or Necater americanus (hookworms)
Measured: Assessed at 6 months
Prevalence of Schistosome infection
The prevalence of Schistosoma mansoni infection
Measured: Assessed at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start11 Dec 2023
- Primary completion1 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Folate DeficiencyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- In randomized control trial, eligible teenage girls attending one of the schools in AM-HDSS will be randomly assigned to: 1. An intervention group receiving a standard bag of cereal flours fortified with folic acid and Vitamin B12 at local mills every week for six months. 2. A placebo group receiving a standard bag of unfortified cereal flours every week for six months. Participants in all the treatment groups remain eligible to benefit from the standard health care and nutrition programs provided at school, such as deworming at the beginning of the school year.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Arba Minch University, Institut de Recherche en Sciences de la Sante, Burkina Faso, Addis Ababa University
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, MD,PHD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100146
- Sponsor's protocol ID
- ONZ-2023-0137-C
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oumer M, Taye M, Aragie H, Tazebew A. Prevalence of Spina Bifida among Newborns in Africa: A Systematic Review and Meta-Analysis. Scientifica (Cairo). 2020 Oct 6;2020:4273510. doi: 10.1155/2020/4273510. eCollection 2020.
PubMed 33083093Wald NJ. Postscript to 'Folic acid and neural tube defects: Discovery, debate and the need for policy change'. J Med Screen. 2022 Sep;29(3):147. doi: 10.1177/09691413221117464. Epub 2022 Aug 8. No abstract available.
PubMed 35942520Ardila A. Development of metacognitive and emotional executive functions in children. Appl Neuropsychol Child. 2013;2(2):82-7. doi: 10.1080/21622965.2013.748388. Epub 2013 Jan 28.
PubMed 23848243Centeno Tablante E, Pachon H, Guetterman HM, Finkelstein JL. Fortification of wheat and maize flour with folic acid for population health outcomes. Cochrane Database Syst Rev. 2019 Jul 1;7(7):CD012150. doi: 10.1002/14651858.CD012150.pub2.
PubMed 31257574Mildon A, Klaas N, O'Leary M, Yiannakis M. Can fortification be implemented in rural African communities where micronutrient deficiencies are greatest? Lessons from projects in Malawi, Tanzania, and Senegal. Food Nutr Bull. 2015 Mar;36(1):3-13. doi: 10.1177/156482651503600101.
PubMed 25898711Tariku EZ, Sorrie MB, Leavitt VM, Demuyakor ME, Gutema BT, Kassa M, Yesera GE, Belete NK, Assefa DT, Egata G, De Henauw S, Abbeddou S. Effects of vitamin B9 and B12-fortified corn flour on cognitive function in teenage girls: a randomized controlled trial in Ethiopia. Eur J Nutr. 2026 Jul 4;65(5):197. doi: 10.1007/s00394-026-04044-1.
PubMed 42400612
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Small Scale Cereal-based Fortification Hold the Key to Improved Micronutrient Status in Ethiopia? The Case of Folic Acid and Vitamin B12 in Teenage Girls in Arba Minch, Ethiopia
- ClinicalTrials.gov ID
- NCT06100146
- Acronym / sponsor ID
- ONZ-2023-0137-C
- Conditions
- Folate Deficiency, Vitamin B 12 Deficiency, Anemia, Megaloblastic, Cognitive Development, Depressive Symptoms
- Keywords
- Small scale fortification, Folic acid, Vitamin B12, Anemia, Cognitive development, Teenage girls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Arba Minch University, Institut de Recherche en Sciences de la Sante, Burkina Faso, Addis Ababa University
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 25 Oct 2023 (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.
Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. A deficiency of either vitamin will predispose teenagers to many diseases, which persist across their lifespan. Fortification of food with micronutrients has been promoted to reduce micronutrient deficiencies. A large segment of vulnerable populations in low- and middle-income countries (LMICs) resides in rural settings and has limited access to large-scale commercialized fortified foods. In such operational constraints, the use of locally (small-scale) fortified cereals could be an alternative intervention. The study aims to evaluate the effectiveness of small scale folic acid and vitamin B12 fortified cereals in improving folate and vitamin B12 status, growth velocity, puberty status, anaemia, cognitive development and mental health among teenage girls, in rural rift valley of Ethiopia.
Detailed description
Folic acid (FA) and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. Teenagers are the future mothers. Hence their health and nutritional status have long term consequences on future pregnancies and birth outcomes. Neural Tube Defects (NTDs) are a group of fatal or severely disabling birth defects known to be mainly a consequence of severe folate deficiency in early pregnancy. The policy of advising women to take iron \& FA (IFA) supplements during pregnancy has not been successful in preventing NTDs because of the low adherence to antenatal care services including IFA, the large proportion of unplanned pregnancies, the timing at which IFA supplementation starts, and the logistical limitation that makes the access to IFA limited. The evidence is strong on the importance of food fortification in the promotion of maternal and child health mainly through reducing micronutrient deficiencies. A large segment of vulnerable populations in developing countries resides in rural settings and has limited access to fortified foods in the market. In such operational constraints, using locally fortified cereals could be an alternative intervention. However, there is a paucity of evidence regarding effectiveness of small-scale cereal-based fortification; in Ethiopia, the evidence is inexistent. Moreover, teenage girls are an under-studied group and do not constitute a target population from different nutritional intervention programs.
The overall objective of this study is to evaluate the effectiveness of small-scale folic acid and vitamin B12-fortified cereals in improving folate and vitamin B12 status, growth velocity, puberty status, anaemia, cognitive development and mental health among rural teenage girls (13-19 years of age).
This study will be conducted in Arba Minch Health and Demographic Surveillance Sites (AM-HDSS), Southern Ethiopia from October 2023 to April 2024. Effectiveness of intake of folic acid and vitamin B12 fortified meals will be evaluated in a randomized, double-blind controlled trial among 474 teenage girls between 13 and 19 years of age who are residing in and attending one of the schools at AM-HDSS.
Data on the following variables, except for demographic characteristics of teenage girls and their respective parents and/or household heads will be collected at the start and end point of the 6 months intervention. Data collection will be carried out at schools and at respective girls' home.
- Demographic characteristics of the teenage girls, morbidity status, helminthic infections, dietary intake, anthropometry, puberty status, presence of depressive symptoms, biochemical samples and cognitive development will be assessed in teenage girls directly at schools.
- Socio-demographic characteristics of the parents or the head of the household if different from parents, family wealth status, food security, health care services and environmental characteristics will be collected in recruited teenage girls' households within the one week following the enrolment and at the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In randomized control trial, eligible teenage girls attending one of the schools in AM-HDSS will be randomly assigned to: 1. An intervention group receiving a standard bag of cereal flours fortified with folic acid and Vitamin B12 at local mills every week for six months. 2. A placebo group receiving a standard bag of unfortified cereal flours every week for six months. Participants in all the treatment groups remain eligible to benefit from the standard health care and nutrition programs provided at school, such as deworming at the beginning of the school year.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Unfortified cereal flourTeenage girls randomly assigned to the control group will receive a standard bag of unfortified cereal flours every week for six months. |
| folic acid & vit B12 fortified flour | Experimental | Dietary Supplement: Folic acid and vitamin B12 fortified flourTeenage girls randomly assigned to the control group will receive a standard bag of cereal flours fortified with folic acid and Vit B12 every week for six months. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Teenage girls between 13 and 19 years of age who live in households at Arba Minch Health and Demographic Surveillance Sites (AM-HDSS) are eligible to participate in the study if:
- One or both of their parents signed an informed consent form and the girl's agreement.
- Their parents and the girl planned to stay in the study area during the period of the study (minimum 6 months) in the kebele.
- Both parents and girls accept the intervention packages including blood draws and home visits.
Key exclusion criteria (6 listed)
- Chronically ill girls diagnosed with diabetes and asthma;
- Severely undernourished girls (defined as body mass index z score < -3 standard deviations of the median World Health Organization reference population);
- Severely anaemic girls (Hb concentration <80g/L);
- Teenage girls who are pregnant, lactating or taking IFA/B12 supplements;
- Diagnosed hemoglobinopathy (sickle cell or thalassemia);
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 |
|---|---|---|
| Folic acid and vitamin B12 fortified flourAlso: Intervention groupStandard bags of fortified cereal-based flours will be prepared at local mills from the common staple cereal food in the area. The dose of vitamins will be added to the flour of the intervention group and mixed with batch mixing technique. The concentration of folic acid and vitamin B12 per 1kg of flour will be 2mg and 0.02mg, respectively. Participants will be supplied with 6 kg bags of flour, which will be enough for 30 days, and 1.5kg bags of flour will be delivered to their home on a weekly basis and lasting for 6 months. Instructions on the preparation of meals and frequency of intake with a weekly compliance sheet will be provided for monitoring the intervention. | Dietary supplement | folic acid & vit B12 fortified flour |
| Unfortified cereal flourAlso: Control groupStandard bags of unfortified cereal-based flours will be prepared at local mills from the common staple cereal food in the area. Participants will be supplied with 6 kg bags of flour, which will be enough for 30 days, and 1.5kg bags of flour will be delivered to their home on a weekly basis and lasting for 6 months. Instructions on the preparation of meals and frequency of intake with a weekly compliance sheet will be provided for monitoring the intervention. | Other | Control group |
Primary outcome
Serum folic acid concentrations
Time frame: Assessed at 6 months
Serum folate levels ng/ml (nmol/l)
Erythrocyte (RBC) folic acid concentrations
Time frame: Assessed at 6 months
RBC folate level ng/ml (nmol/l)
General cognitive ability
Time frame: Assessed at 6 months
Raven Progressive Matrices (RPM) tests, a measure of nonverbal intelligence.
Working memory
Time frame: Assessed at 6 months
Digit Span (Forward, Backward, and Sequencing) is a standardized test that assesses the working memory of participants.
Depression
Time frame: Assessed at 6 months
Depressive symptoms will be assessed by Patient Health Questionnaire (PHQ) 9 modified for adolescents (PHQ-9A), a self-report instrument comprised of 9-items. Items are rated on a four-point ordinal scale.
Serum vitamin B12 concentrations
Time frame: Assessed at 6 months
Serum vitamin B12 level (pmol/L)
Fat-free mass
Time frame: Assessed at 6 months
An index of adiposity will be measured to evaluate girls' body composition, in %
Fat mass
Time frame: Assessed at 6 months
An index of adiposity will be measured to evaluate girls' body composition, in kg
9 secondary outcomes
RBC structure (megaloblastic anaemia)
Time frame: Assessed at 6 months
Plasma homocysteine concentrations
Time frame: Assessed at 6 months
Weight
Time frame: Assessed at 3 and 6 months
Adherence to the intervention/fortification
Time frame: Assessed weekly for the whole period of intervention (until 6 months)
Haemoglobin concentration
Time frame: Assessed at 6 months
Height
Time frame: Assessed at 6 months
Puberty status
Time frame: Assessed at 6 months of fortification
Prevalence of soil-transmitted helminths
Time frame: Assessed at 6 months
Prevalence of Schistosome infection
Time frame: Assessed at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 33083093Oumer M, Taye M, Aragie H, Tazebew A. Prevalence of Spina Bifida among Newborns in Africa: A Systematic Review and Meta-Analysis. Scientifica (Cairo). 2020 Oct 6;2020:4273510. doi: 10.1155/2020/4273510. eCollection 2020.
- Background: PubMed 35942520Wald NJ. Postscript to 'Folic acid and neural tube defects: Discovery, debate and the need for policy change'. J Med Screen. 2022 Sep;29(3):147. doi: 10.1177/09691413221117464. Epub 2022 Aug 8. No abstract available.
- Background: PubMed 23848243Ardila A. Development of metacognitive and emotional executive functions in children. Appl Neuropsychol Child. 2013;2(2):82-7. doi: 10.1080/21622965.2013.748388. Epub 2013 Jan 28.
- Background: PubMed 31257574Centeno Tablante E, Pachon H, Guetterman HM, Finkelstein JL. Fortification of wheat and maize flour with folic acid for population health outcomes. Cochrane Database Syst Rev. 2019 Jul 1;7(7):CD012150. doi: 10.1002/14651858.CD012150.pub2.
- Background: PubMed 25898711Mildon A, Klaas N, O'Leary M, Yiannakis M. Can fortification be implemented in rural African communities where micronutrient deficiencies are greatest? Lessons from projects in Malawi, Tanzania, and Senegal. Food Nutr Bull. 2015 Mar;36(1):3-13. doi: 10.1177/156482651503600101.
- Derived from this study: PubMed 42400612Tariku EZ, Sorrie MB, Leavitt VM, Demuyakor ME, Gutema BT, Kassa M, Yesera GE, Belete NK, Assefa DT, Egata G, De Henauw S, Abbeddou S. Effects of vitamin B9 and B12-fortified corn flour on cognitive function in teenage girls: a randomized controlled trial in Ethiopia. Eur J Nutr. 2026 Jul 4;65(5):197. doi: 10.1007/s00394-026-04044-1.
- 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.
Stefaan De Henauw, MD,PHD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid and vitamin B12 fortified flour and Unfortified cereal flour in people with Folate Deficiency and Vitamin B 12 Deficiency, run by University Ghent at 2 sites in Ethiopia.
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 6 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: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum folic acid concentrations (time frame: Assessed at 6 months). The study lists 8 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 NCT06100146, which also lists 6 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 14 Aug 2026.