GrowthNCT05771324
The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development
A study testing Baby-Led Weaning (BLW) and Traditional Complementary Feeding (TCF) in people with Growth and Infant Development, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this [type of study: clinical trial] is to compare compare the nutrition, development, obesity risk and anemia risk of the infant with the BLW method and TCF method given to the mothers of infants who have switched to complementary feeding. Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth, Infant Development, Complementary Feeding
- What is being tested?
- Baby-Led Weaning (BLW) and Traditional Complementary Feeding (TCF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2021to 18 Apr 2022
- 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 4 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- for mothers;
- The fact that the mothers came to the center where the research will be conducted for routine baby follow-up and vaccination follow-up.
- Mothers' willingness to participate in the research
- Absence of any communication problems
- The mothers must be at least 19 years old.
- Mothers have no physical or mental disability
Show all 13Show fewer
- for babies;
- . Babies must be at least 4 months and maximum 6 months old when they are included in the study.
- Complementary feeding not yet started
- Babies being fed only with breast milk
- Babies not born before 38 weeks of gestation
- Absence of a congenital anomaly
- Absence of any digestive and neurological system diseases that may affect nutrition
Who cannot join
- Infants and mothers who did not meet the inclusion criteria were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development Randomized Controlled Trial
The goal of this [type of study: clinical trial] is to compare compare the nutrition, development, obesity risk and anemia risk of the infant with the BLW method and TCF method given to the mothers of infants who have switched to complementary feeding. The main question[s] it aims to answer are:
- Does the training on the GTB and BLW method given in accordance with the developmental age of the baby in months have an effect on the feeding and development of the babies in both groups?
- Does the training on the GTB and BLW method given in accordance with the developmental age of the baby in months have an effect on the obesity risk and anemia risk of babies in both groups?
Read more
Participants will participate in each session of the complementary nutrition trainings given in accordance with their age on a monthly basis and will provide a diet suitable for the trainings.
Researchers will compare the nutritional parameters, developmental levels, and height and weight gains of infants fed with the BLW and TCF method to see the effect of complementary feeding education on the nutrition and development of infants and whether there is anemia and obesity risk.
Read the detailed description
Regarding the basic questions that the study aims to answer;
Micronutrient intake, hemoglobin, ferritin and vitamin B12 levels were evaluated to examine the effects of the trainings on infant nutrition.
Physical, cognitive, psychosocial, language, motor and game development levels of infants were evaluated in order to examine the effects of training on infant development.
Weight gain, WLZ, LAZ and WAZ scores of infants were evaluated to examine the effects of the education given on obesity risk.
Hemoglobin, hematocrit and ferritin levels were evaluated to examine the effects of the training given on the risk of anemia.
- Conditions
- Growth, Infant Development, Complementary Feeding, Nutrition, Healthy, Anemia, Iron Deficiency, Obesity, Infant
- Being tested
- Baby-Led Weaning (BLW), Traditional Complementary Feeding (TCF)
- Keywords
- Growth, Infant Development, Complementary Feeding, Nutrition, Healthy, Anemia, Iron Deficiency, Obesity, Infant, solid food
- Medical subject headings
- Anemia, Iron-Deficiency, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby-Led Weaning (BLW)Other
Also called BLW
BLW trainings given to mothers for 6-12 month old babies
Traditional Complementary Feeding (TCF)Other
Also called TCF
TCF trainings given to mothers for 6-12 month old babies
| Study group | Role | What they receive |
|---|---|---|
| Baby-Led Weaning (BLW) | Experimental | The group named for infants who received complementary feeding education with the BLW method and who were fed with the BLW method. Receives: Other: Baby-Led Weaning (BLW) |
| Traditional Complementary Feeding (TCF) | Experimental | The group named for infants who received complementary nutrition education with the TCF method and who were fed with the TCF method. Receives: Other: Traditional Complementary Feeding (TCF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on infant growth
BMI of babies were used as growth criteria. In addition, Z-score values for BMI were examined according to WHO standards.
Measured: Examining the change at 12 months
Effect on infant developmenter parameter
In the evaluation of infant development, motor developmental evaluation criteria used as standard in the national infant follow-ups of the T.C. Ministry of Health were used.
Measured: Examining the change at 12 months
Effect on infant anemia and iron deficiency
Iron levels in infants were examined.
Measured: Examining the change at 12 months.
Effect on infant obesity risk
The 12-month BMI distributions of the groups were analyzed.
Measured: Examining the change at 12 months.
Secondary outcomes (3)
Early transition to solid food
Solid food intake time in infants in both groups was evaluated as months
Measured: Examining the change at 12 months.
Early transition to self feeding
Self feeding time in infants in both groups was evaluated as months
Measured: Examining the change at 12 months
Early transition to family meals
Family meals time in infants in both groups was evaluated as months
Measured: Examining the change at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start18 Jan 2021
- Primary completion18 Apr 2021
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies 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
- The sample size of the study consisted of 62 people according to the power analysis. Block and stratified randomization methods were used in the selection of the experimental groups. When the literature is examined, there are studies showing the effect of mothers' education level and previous complementary food experiences on the transition to solid food. Accordingly, stratification was made according to the education level of the mothers and the number of children. Thus, two people were assigned homogeneously in each block according to the education level of the mothers and the number of children. Randomization was done by the Outcome Evaluator independently of the investigators. The research was carried out according to the Consort 2010 Flow Chart and the study was concluded with 56 people.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten ARSLAN, Zonguldak Bulent Ecevit University
- Investigators
- NURTEN ARSLAN, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771324
- Sponsor's protocol ID
- nurten.arslan
- Other IDs
- 2020-19093093-02
- Status last verified
- Mar 2023
- First submitted
- 5 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researcher who made the evaluation did not have information about the experimental groups and which group the individuals were assigned to.
Publications
Cameron SL, Taylor RW, Heath AL. Development and pilot testing of Baby-Led Introduction to SolidS--a version of Baby-Led Weaning modified to address concerns about iron deficiency, growth faltering and choking. BMC Pediatr. 2015 Aug 26;15:99. doi: 10.1186/s12887-015-0422-8.
PubMed 26306667Cameron SL, Taylor RW, Heath AL. Parent-led or baby-led? Associations between complementary feeding practices and health-related behaviours in a survey of New Zealand families. BMJ Open. 2013 Dec 9;3(12):e003946. doi: 10.1136/bmjopen-2013-003946.
PubMed 24327363Cameron SL, Heath AL, Taylor RW. How feasible is Baby-led Weaning as an approach to infant feeding? A review of the evidence. Nutrients. 2012 Nov 2;4(11):1575-609. doi: 10.3390/nu4111575.
PubMed 23201835Daniels L, Taylor RW, Williams SM, Gibson RS, Fleming EA, Wheeler BJ, Taylor BJ, Haszard JJ, Heath AM. Impact of a modified version of baby-led weaning on iron intake and status: a randomised controlled trial. BMJ Open. 2018 Jun 27;8(6):e019036. doi: 10.1136/bmjopen-2017-019036.
PubMed 29950456Daniels L, Heath AL, Williams SM, Cameron SL, Fleming EA, Taylor BJ, Wheeler BJ, Gibson RS, Taylor RW. Baby-Led Introduction to SolidS (BLISS) study: a randomised controlled trial of a baby-led approach to complementary feeding. BMC Pediatr. 2015 Nov 12;15:179. doi: 10.1186/s12887-015-0491-8.
PubMed 26563757Williams Erickson L, Taylor RW, Haszard JJ, Fleming EA, Daniels L, Morison BJ, Leong C, Fangupo LJ, Wheeler BJ, Taylor BJ, Te Morenga L, McLean RM, Heath AM. Impact of a Modified Version of Baby-Led Weaning on Infant Food and Nutrient Intakes: The BLISS Randomized Controlled Trial. Nutrients. 2018 Jun 7;10(6):740. doi: 10.3390/nu10060740.
PubMed 29880769Morison BJ, Taylor RW, Haszard JJ, Schramm CJ, Williams Erickson L, Fangupo LJ, Fleming EA, Luciano A, Heath AL. How different are baby-led weaning and conventional complementary feeding? A cross-sectional study of infants aged 6-8 months. BMJ Open. 2016 May 6;6(5):e010665. doi: 10.1136/bmjopen-2015-010665.
PubMed 27154478Robert RC, Creed-Kanashiro HM, Villasante R, Narro MR, Penny ME. Strengthening health services to deliver nutrition education to promote complementary feeding and healthy growth of infants and young children: formative research for a successful intervention in peri-urban Trujillo, Peru. Matern Child Nutr. 2017 Apr;13(2):e12264. doi: 10.1111/mcn.12264. Epub 2016 Mar 2.
PubMed 26931182Taylor RW, Williams SM, Fangupo LJ, Wheeler BJ, Taylor BJ, Daniels L, Fleming EA, McArthur J, Morison B, Erickson LW, Davies RS, Bacchus S, Cameron SL, Heath AM. Effect of a Baby-Led Approach to Complementary Feeding on Infant Growth and Overweight: A Randomized Clinical Trial. JAMA Pediatr. 2017 Sep 1;171(9):838-846. doi: 10.1001/jamapediatrics.2017.1284.
PubMed 28692728Brown A, Lee M. An exploration of experiences of mothers following a baby-led weaning style: developmental readiness for complementary foods. Matern Child Nutr. 2013 Apr;9(2):233-43. doi: 10.1111/j.1740-8709.2011.00360.x. Epub 2011 Nov 28.
PubMed 22118242Sazawal S, Dhingra P, Dhingra U, Gupta S, Iyengar V, Menon VP, Sarkar A, Black RE. Compliance with home-based fortification strategies for delivery of iron and zinc: its effect on haematological and growth markers among 6-24 months old children in north India. J Health Popul Nutr. 2014 Jun;32(2):217-26.
PubMed 25076659D'Auria E, Bergamini M, Staiano A, Banderali G, Pendezza E, Penagini F, Zuccotti GV, Peroni DG; Italian Society of Pediatrics. Baby-led weaning: what a systematic review of the literature adds on. Ital J Pediatr. 2018 May 3;44(1):49. doi: 10.1186/s13052-018-0487-8.
PubMed 29724233ESPGHAN Committee on Nutrition; Agostoni C, Braegger C, Decsi T, Kolacek S, Koletzko B, Michaelsen KF, Mihatsch W, Moreno LA, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J. Breast-feeding: A commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2009 Jul;49(1):112-25. doi: 10.1097/MPG.0b013e31819f1e05.
PubMed 19502997Alvisi P, Brusa S, Alboresi S, Amarri S, Bottau P, Cavagni G, Corradini B, Landi L, Loroni L, Marani M, Osti IM, Povesi-Dascola C, Caffarelli C, Valeriani L, Agostoni C. Recommendations on complementary feeding for healthy, full-term infants. Ital J Pediatr. 2015 Apr 28;41:36. doi: 10.1186/s13052-015-0143-5.
PubMed 25928205Brown A, Jones SW, Rowan H. Baby-Led Weaning: The Evidence to Date. Curr Nutr Rep. 2017;6(2):148-156. doi: 10.1007/s13668-017-0201-2. Epub 2017 Apr 29.
PubMed 28596930
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05771324
- Acronym / sponsor ID
- nurten.arslan
- Conditions
- Growth, Infant Development, Complementary Feeding, Nutrition, Healthy, Anemia, Iron Deficiency, Obesity, Infant
- Keywords
- Growth, Infant Development, Complementary Feeding, Nutrition, Healthy, Anemia, Iron Deficiency, Obesity, Infant, solid food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 16 Mar 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.
The goal of this [type of study: clinical trial] is to compare compare the nutrition, development, obesity risk and anemia risk of the infant with the BLW method and TCF method given to the mothers of infants who have switched to complementary feeding. The main question[s] it aims to answer are:
- Does the training on the GTB and BLW method given in accordance with the developmental age of the baby in months have an effect on the feeding and development of the babies in both groups?
- Does the training on the GTB and BLW method given in accordance with the developmental age of the baby in months have an effect on the obesity risk and anemia risk of babies in both groups?
Participants will participate in each session of the complementary nutrition trainings given in accordance with their age on a monthly basis and will provide a diet suitable for the trainings.
Researchers will compare the nutritional parameters, developmental levels, and height and weight gains of infants fed with the BLW and TCF method to see the effect of complementary feeding education on the nutrition and development of infants and whether there is anemia and obesity risk.
Detailed description
Regarding the basic questions that the study aims to answer;
Micronutrient intake, hemoglobin, ferritin and vitamin B12 levels were evaluated to examine the effects of the trainings on infant nutrition.
Physical, cognitive, psychosocial, language, motor and game development levels of infants were evaluated in order to examine the effects of training on infant development.
Weight gain, WLZ, LAZ and WAZ scores of infants were evaluated to examine the effects of the education given on obesity risk.
Hemoglobin, hematocrit and ferritin levels were evaluated to examine the effects of the training given on the risk of anemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The sample size of the study consisted of 62 people according to the power analysis. Block and stratified randomization methods were used in the selection of the experimental groups. When the literature is examined, there are studies showing the effect of mothers' education level and previous complementary food experiences on the transition to solid food. Accordingly, stratification was made according to the education level of the mothers and the number of children. Thus, two people were assigned homogeneously in each block according to the education level of the mothers and the number of children. Randomization was done by the Outcome Evaluator independently of the investigators. The research was carried out according to the Consort 2010 Flow Chart and the study was concluded with 56 people.
| Arm | Type | Receives |
|---|---|---|
| Baby-Led Weaning (BLW) | Experimental | Other: Baby-Led Weaning (BLW)The group named for infants who received complementary feeding education with the BLW method and who were fed with the BLW method. |
| Traditional Complementary Feeding (TCF) | Experimental | Other: Traditional Complementary Feeding (TCF)The group named for infants who received complementary nutrition education with the TCF method and who were fed with the TCF method. |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- for mothers;
- The fact that the mothers came to the center where the research will be conducted for routine baby follow-up and vaccination follow-up.
- Mothers' willingness to participate in the research
- Absence of any communication problems
- The mothers must be at least 19 years old.
Key exclusion criteria (1 listed)
- Infants and mothers who did not meet the inclusion criteria were not included in the study.
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 |
|---|---|---|
| Baby-Led Weaning (BLW)Also: BLWBLW trainings given to mothers for 6-12 month old babies | Other | Baby-Led Weaning (BLW) |
| Traditional Complementary Feeding (TCF)Also: TCFTCF trainings given to mothers for 6-12 month old babies | Other | Traditional Complementary Feeding (TCF) |
Primary outcome
Effect on infant growth
Time frame: Examining the change at 12 months
BMI of babies were used as growth criteria. In addition, Z-score values for BMI were examined according to WHO standards.
Effect on infant developmenter parameter
Time frame: Examining the change at 12 months
In the evaluation of infant development, motor developmental evaluation criteria used as standard in the national infant follow-ups of the T.C. Ministry of Health were used.
Effect on infant anemia and iron deficiency
Time frame: Examining the change at 12 months.
Iron levels in infants were examined.
Effect on infant obesity risk
Time frame: Examining the change at 12 months.
The 12-month BMI distributions of the groups were analyzed.
3 secondary outcomes
Early transition to solid food
Time frame: Examining the change at 12 months.
Early transition to self feeding
Time frame: Examining the change at 12 months
Early transition to family meals
Time frame: Examining the change at 12 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 16 Mar 2023.
- Background: PubMed 26306667Cameron SL, Taylor RW, Heath AL. Development and pilot testing of Baby-Led Introduction to SolidS--a version of Baby-Led Weaning modified to address concerns about iron deficiency, growth faltering and choking. BMC Pediatr. 2015 Aug 26;15:99. doi: 10.1186/s12887-015-0422-8.
- Background: PubMed 24327363Cameron SL, Taylor RW, Heath AL. Parent-led or baby-led? Associations between complementary feeding practices and health-related behaviours in a survey of New Zealand families. BMJ Open. 2013 Dec 9;3(12):e003946. doi: 10.1136/bmjopen-2013-003946.
- Background: PubMed 23201835Cameron SL, Heath AL, Taylor RW. How feasible is Baby-led Weaning as an approach to infant feeding? A review of the evidence. Nutrients. 2012 Nov 2;4(11):1575-609. doi: 10.3390/nu4111575.
- Background: PubMed 29950456Daniels L, Taylor RW, Williams SM, Gibson RS, Fleming EA, Wheeler BJ, Taylor BJ, Haszard JJ, Heath AM. Impact of a modified version of baby-led weaning on iron intake and status: a randomised controlled trial. BMJ Open. 2018 Jun 27;8(6):e019036. doi: 10.1136/bmjopen-2017-019036.
- Background: PubMed 26563757Daniels L, Heath AL, Williams SM, Cameron SL, Fleming EA, Taylor BJ, Wheeler BJ, Gibson RS, Taylor RW. Baby-Led Introduction to SolidS (BLISS) study: a randomised controlled trial of a baby-led approach to complementary feeding. BMC Pediatr. 2015 Nov 12;15:179. doi: 10.1186/s12887-015-0491-8.
- Background: PubMed 29880769Williams Erickson L, Taylor RW, Haszard JJ, Fleming EA, Daniels L, Morison BJ, Leong C, Fangupo LJ, Wheeler BJ, Taylor BJ, Te Morenga L, McLean RM, Heath AM. Impact of a Modified Version of Baby-Led Weaning on Infant Food and Nutrient Intakes: The BLISS Randomized Controlled Trial. Nutrients. 2018 Jun 7;10(6):740. doi: 10.3390/nu10060740.
- Background: PubMed 27154478Morison BJ, Taylor RW, Haszard JJ, Schramm CJ, Williams Erickson L, Fangupo LJ, Fleming EA, Luciano A, Heath AL. How different are baby-led weaning and conventional complementary feeding? A cross-sectional study of infants aged 6-8 months. BMJ Open. 2016 May 6;6(5):e010665. doi: 10.1136/bmjopen-2015-010665.
- Background: PubMed 26931182Robert RC, Creed-Kanashiro HM, Villasante R, Narro MR, Penny ME. Strengthening health services to deliver nutrition education to promote complementary feeding and healthy growth of infants and young children: formative research for a successful intervention in peri-urban Trujillo, Peru. Matern Child Nutr. 2017 Apr;13(2):e12264. doi: 10.1111/mcn.12264. Epub 2016 Mar 2.
- Background: PubMed 28692728Taylor RW, Williams SM, Fangupo LJ, Wheeler BJ, Taylor BJ, Daniels L, Fleming EA, McArthur J, Morison B, Erickson LW, Davies RS, Bacchus S, Cameron SL, Heath AM. Effect of a Baby-Led Approach to Complementary Feeding on Infant Growth and Overweight: A Randomized Clinical Trial. JAMA Pediatr. 2017 Sep 1;171(9):838-846. doi: 10.1001/jamapediatrics.2017.1284.
- Background: PubMed 22118242Brown A, Lee M. An exploration of experiences of mothers following a baby-led weaning style: developmental readiness for complementary foods. Matern Child Nutr. 2013 Apr;9(2):233-43. doi: 10.1111/j.1740-8709.2011.00360.x. Epub 2011 Nov 28.
- Background: PubMed 25076659Sazawal S, Dhingra P, Dhingra U, Gupta S, Iyengar V, Menon VP, Sarkar A, Black RE. Compliance with home-based fortification strategies for delivery of iron and zinc: its effect on haematological and growth markers among 6-24 months old children in north India. J Health Popul Nutr. 2014 Jun;32(2):217-26.
- Background: PubMed 29724233D'Auria E, Bergamini M, Staiano A, Banderali G, Pendezza E, Penagini F, Zuccotti GV, Peroni DG; Italian Society of Pediatrics. Baby-led weaning: what a systematic review of the literature adds on. Ital J Pediatr. 2018 May 3;44(1):49. doi: 10.1186/s13052-018-0487-8.
- Individual participant dataSharing planned: Yes. The researcher who made the evaluation did not have information about the experimental groups and which group the individuals were assigned to.
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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.
NURTEN ARSLAN principal investigator
Zonguldak Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby-Led Weaning (BLW) and Traditional Complementary Feeding (TCF) in people with Growth and Infant Development, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 13 inclusion and 1 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 16 Mar 2023. 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 Turkey (Türkiye). 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?
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?
Effect on infant growth (time frame: Examining the change at 12 months). The study lists 4 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 NCT05771324, which also lists 17 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 16 Mar 2023.