MalnutritionFAARMNCT02505711
Food and Agricultural Approaches to Reducing Malnutrition
A study testing Homestead Food Production program in people with Malnutrition, run by Sabine Gabrysch.
Trial summary
The aim of this study is to evaluate the potential of reducing young child undernutrition in low-income countries through an integrated program that trains women's groups in agriculture, nutrition, child care and hygiene. Read more about this study
- Who is it for?
- Ages 15 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Homestead Food Production program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,705 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2015to 30 Aug 2021
- 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 15 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For settlements:
- Located in selected unions of Habiganj District, Sylhet Division, North East Bangladesh
- Minimum distance to adjacent settlement at least 400 m
- Judged to be suitable for Homestead Food Production program by the NGO HKI Bangladesh (dry land year-round, at least 10 women eligible and interested)
- For women:
- Married and aged 30 years or less at enumeration
Show all 11Show fewer
- Woman's husband stays overnight in household at least once a year
- Access to at least 1 decimal of land, ideally 0.25 decimal near the house
- For children:
- Biological child of a participant woman
- Aged 0-35 months at survey start or surveillance visit
Who cannot join
- For women:
- Lack of interest in participating in a gardening program
About this study
Official title: Reducing Young Child Undernutrition Through an Integrated Agricultural Project With Women's Groups: A Cluster-randomized Trial in Rural Bangladesh
The aim of this study is to evaluate the potential of reducing young child undernutrition in low-income countries through an integrated program that trains women's groups in agriculture, nutrition, child care and hygiene.
Read the detailed description
An estimated 165 million children worldwide suffer from chronic undernutrition which leads to compromised physical and cognitive development and prevents them from reaching their full potential. Nutrition-sensitive agricultural interventions that aim to increase dietary diversity, empower women and include an educational behaviour change component focused on nutrition and hygiene are a promising and sustainable approach to addressing undernutrition. However, evidence on the impact of such interventions is still scarce due to a lack of rigorous long-term evaluations.
This study will test the hypothesis that integrated agriculture, nutrition and hygiene interventions can reduce undernutrition when children benefit in their crucial first 1000 days. The investigators will conduct an impact evaluation of Helen Keller International's Homestead Food Production program in Bangladesh that trains women's groups in vegetable and fruit gardening, poultry rearing, hygiene, child care and nutrition. Furthermore, the investigators will assess the program impact pathway to discern how any impact is achieved (through improved food production, income, food security, health service use, female empowerment, feeding and hygiene practices).
The study design is a cluster-randomized controlled field trial in two sub-districts of Habiganj District, Sylhet Division, Bangladesh, including 2700 young women in 96 settlements. After the baseline survey in 2015, settlements will be randomized into 48 intervention and 48 control settlements. Women in the intervention settlements will receive training and support in Homestead Food Production during the following four years. A surveillance system will collect data on pregnancies, births, child development, nutrition and infections as well as pathway indicators. In 2019, the investigators will conduct the endline survey to assess the nutritional status of the 2700 women and their then approximately 1500 children below 3 years of age and compare between intervention and control.
- Conditions
- Malnutrition
- Being tested
- Homestead Food Production program
- Keywords
- Agriculture, Food, Micronutrients, Pregnancy, Infants, Women's groups, Bangladesh
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homestead Food Production programBehavioural
Also called Agriculture, Home gardening, Nutrition education
Training and support for vegetable gardening and poultry rearing, and education on young child nutrition, hygiene and health topics, in women's groups, as designed by the international non-governmental organization (NGO) Helen Keller International (HKI).
| Study group | Role | What they receive |
|---|---|---|
| Homestead Food Production | Experimental | Enrolled in Homestead Food Production program from 2015 to 2019, 48 clusters, approx. 1350 women and 750 children Receives: Behavioral: Homestead Food Production program |
| Control | No intervention | (Health system strengthening in the study area), 48 clusters, approx. 1350 women and 750 children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth in children below 3 years of age
Length/height-for-age Z-score
Measured: Measured 50 months after randomization (endline survey 2019)
Secondary outcomes (20)
Linear growth in children aged 6-30 months
Length/height-for-age Z-score
Measured: Measured 50 months after randomization
Intrauterine growth retardation: length
Length-for-gestational-age
Measured: Measured within 3 days of birth, 15-57 months after randomization
Intrauterine growth retardation: small-for-gestational age
Weight-for-gestational-age adjusted for time since birth
Measured: Measured within 3 days of birth, 15-57 months after randomization
Intrauterine growth retardation: head size
Head circumference-for-gestational-age
Measured: Measured within 3 days of birth, 15-57 months after randomization
Wasting in children below 3 years of age
Weight-for-length/height Z-score
Measured: Measured 50 months after randomization
Head circumference in children below 3 years of age
Head circumference-for-age Z-score
Measured: Measured 50 months after randomization
Underweight in women
Body Mass Index (BMI, non-pregnant women), mid-upper-arm circumference (MUAC, pregnant women)
Measured: Measured 50 months after randomization
Gestational weight gain
Gestational weight gain Z-score
Measured: Measured every 2 months during pregnancy, 6-57 months after randomization
Anemia in women and children below 3 years of age
Hemoglobin concentration
Measured: Measured 50 months after randomization
Micronutrients: Vitamin A deficiency in women and in children below 3 years of age
Retinol-binding protein, corrected for inflammation (CRP, AGP)
Measured: Measured 50 months after randomization
Micronutrients: Iron deficiency in women and in children below 3 years of age
Ferritin and soluble transferrin receptor, corrected for inflammation (CRP, AGP)
Measured: Measured 50 months after randomization
Micronutrients: Zinc deficiency in women and in children below 3 years of age
Serum zinc, corrected for inflammation (CRP, AGP)
Measured: Measured 50 months after randomization
Early child development (adapted WHO milestones)
Gross and fine motor, cognitive, personal-social and communication skills
Measured: Measured at appropriate ages for milestones, 6-50 months after randomization
Diarrhea in children below 3 years of age
Period and point prevalence of diarrhea
Measured: Measured every 2 months, 6-50 months after randomization
Acute respiratory infection in children below 3 years of age
Period prevalence of acute respiratory infection
Measured: Measured every 2 months, 6-50 months after randomization
Enteropathy in children below 18 months of age
Biomarkers: faecal myeloperoxidase, faecal α1-antitrypsin, faecal neopterin, serum C-reactive protein, serum α-1-acid glycoprotein
Measured: Measured 36 and 50 months after randomization
Dietary adequacy in women and children below 3 years of age
Mean probability of adequate micronutrient intake (MPA)
Measured: Measured every 2 months, 6-50 months after randomization
Dietary diversity in women and children below 3 years of age
Individual dietary diversity score, breastfeeding behaviors
Measured: Measured every 2 months, 6-50 months after randomization
Fecal contamination of complementary food for children 6-18 months of age
Log-transformed counts of total coliforms and E. coli in complementary food samples
Measured: Measured 36 months after randomization
Food hygiene behaviour in mothers of children aged 6-18 months
Hygiene score from structured observation of mothers
Measured: Measured 36 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start14 Mar 2015
- Primary completion15 Feb 2020
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sabine Gabrysch
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International, BRAC University, University of Giessen, German Federal Ministry of Education and Research, Department for International Development, United Kingdom, International Centre for Diarrhoeal Disease Research, Bangladesh, German Research Foundation
- Responsible party
- Sponsor-investigator, Sabine Gabrysch, Heidelberg University
- Investigators
- Sabine Gabrysch, MD MSc PhD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505711
- Sponsor's protocol ID
- 01ER1201
- Acronym
- FAARM
- Status last verified
- May 2022
- First submitted
- 17 Jul 2015
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sparling TM, Cornejo C, Offner C, Mayer A, Waid JL, Kadiyala S, Gabrysch S. Nutrition-sensitive agriculture programme impacts women's mental health via food security in rural Bangladesh. BMJ Glob Health. 2026 May 5;11(5):e020509. doi: 10.1136/bmjgh-2025-020509.
PubMed 42086300Wendt AS, Waid JL, Muller-Hauser AA, Lambrecht NJ, Huda TMN, Kyei NNA, Gabrysch S. Impacts of a Homestead Food Production Intervention on Anaemia and Micronutrient Deficiencies Among Women and Children in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Matern Child Nutr. 2025 Oct;21(4):e70043. doi: 10.1111/mcn.70043. Epub 2025 May 19.
PubMed 40387380Sobhan S, Muller-Hauser AA, Gon G, Nurul Huda TM, Waid JL, Wendt AS, Rahman M, Gabrysch S. Effect of a behaviour change intervention on household food hygiene practices in rural Bangladesh: A cluster-randomised controlled trial. Int J Hyg Environ Health. 2024 Jan;255:114291. doi: 10.1016/j.ijheh.2023.114291. Epub 2023 Nov 18.
PubMed 37983985Waid JL, Wendt AS, Kader A, Sobhan S, Gabrysch S. Impact of a Homestead Food Production Program on Dietary Diversity: Seasonal and Annual Results from the Cluster-Randomized FAARM Trial in Sylhet, Bangladesh. J Nutr. 2024 Jan;154(1):191-201. doi: 10.1016/j.tjnut.2023.10.014. Epub 2023 Oct 21.
PubMed 37871747Muller-Hauser AA, Huda TMN, Sobhan S, Lambrecht NJ, Waid JL, Wendt AS, Ali S, Rahman M, Gabrysch S. Effect of a Homestead Food Production and Food Hygiene Intervention on Biomarkers of Environmental Enteric Dysfunction in Children Younger Than 24 Months in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Oct 2;109(5):1166-1176. doi: 10.4269/ajtmh.23-0153. Print 2023 Nov 1.
PubMed 37783459Lambrecht NJ, Muller-Hauser AA, Sobhan S, Schmidt WP, Huda TMN, Waid JL, Wendt AS, Kader A, Gabrysch S. Effect of a Homestead Food Production Program on the Prevalence of Diarrhea and Acute Respiratory Infection in Children in Sylhet, Bangladesh: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Aug 14;109(4):945-956. doi: 10.4269/ajtmh.23-0152. Print 2023 Oct 4.
PubMed 37580032Dupuis S, Hennink M, Wendt AS, Waid JL, Kalam MA, Gabrysch S, Sinharoy SS. Women's empowerment through homestead food production in rural Bangladesh. BMC Public Health. 2022 Jan 19;22(1):134. doi: 10.1186/s12889-022-12524-2.
PubMed 35045859Wendt AS, Waid JL, Gabrysch S. Dietary Factors Moderate the Relation between Groundwater Iron and Anemia in Women and Children in Rural Bangladesh. Curr Dev Nutr. 2019 Aug 6;3(10):nzz093. doi: 10.1093/cdn/nzz093. eCollection 2019 Oct.
PubMed 31620671Wendt AS, Sparling TM, Waid JL, Mueller AA, Gabrysch S. Food and Agricultural Approaches to Reducing Malnutrition (FAARM): protocol for a cluster-randomised controlled trial to evaluate the impact of a Homestead Food Production programme on undernutrition in rural Bangladesh. BMJ Open. 2019 Jul 4;9(7):e031037. doi: 10.1136/bmjopen-2019-031037.
PubMed 31278109
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Young Child Undernutrition Through an Integrated Agricultural Project With Women's Groups: A Cluster-randomized Trial in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT02505711
- Acronym / sponsor ID
- FAARM / 01ER1201
- Conditions
- Malnutrition
- Keywords
- Agriculture, Food, Micronutrients, Pregnancy, Infants, Women's groups, Bangladesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,705 participants (actual)
- Lead sponsor
- Sabine GabryschUniversity, hospital or other
- Collaborators
- Helen Keller International, BRAC University, University of Giessen, German Federal Ministry of Education and Research, Department for International Development, United Kingdom, International Centre for Diarrhoeal Disease Research, Bangladesh, German Research Foundation
- Study start
- 14 Mar 2015 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 Jul 2015 (estimated)
- 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 aim of this study is to evaluate the potential of reducing young child undernutrition in low-income countries through an integrated program that trains women's groups in agriculture, nutrition, child care and hygiene.
Detailed description
An estimated 165 million children worldwide suffer from chronic undernutrition which leads to compromised physical and cognitive development and prevents them from reaching their full potential. Nutrition-sensitive agricultural interventions that aim to increase dietary diversity, empower women and include an educational behaviour change component focused on nutrition and hygiene are a promising and sustainable approach to addressing undernutrition. However, evidence on the impact of such interventions is still scarce due to a lack of rigorous long-term evaluations.
This study will test the hypothesis that integrated agriculture, nutrition and hygiene interventions can reduce undernutrition when children benefit in their crucial first 1000 days. The investigators will conduct an impact evaluation of Helen Keller International's Homestead Food Production program in Bangladesh that trains women's groups in vegetable and fruit gardening, poultry rearing, hygiene, child care and nutrition. Furthermore, the investigators will assess the program impact pathway to discern how any impact is achieved (through improved food production, income, food security, health service use, female empowerment, feeding and hygiene practices).
The study design is a cluster-randomized controlled field trial in two sub-districts of Habiganj District, Sylhet Division, Bangladesh, including 2700 young women in 96 settlements. After the baseline survey in 2015, settlements will be randomized into 48 intervention and 48 control settlements. Women in the intervention settlements will receive training and support in Homestead Food Production during the following four years. A surveillance system will collect data on pregnancies, births, child development, nutrition and infections as well as pathway indicators. In 2019, the investigators will conduct the endline survey to assess the nutritional status of the 2700 women and their then approximately 1500 children below 3 years of age and compare between intervention and control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homestead Food Production | Experimental | Behavioral: Homestead Food Production programEnrolled in Homestead Food Production program from 2015 to 2019, 48 clusters, approx. 1350 women and 750 children |
| Control | No intervention | –(Health system strengthening in the study area), 48 clusters, approx. 1350 women and 750 children |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Located in selected unions of Habiganj District, Sylhet Division, North East Bangladesh
- Minimum distance to adjacent settlement at least 400 m
- Judged to be suitable for Homestead Food Production program by the NGO HKI Bangladesh (dry land year-round, at least 10 women eligible and interested)
- Married and aged 30 years or less at enumeration
- Woman's husband stays overnight in household at least once a year
Key exclusion criteria (2 listed)
- Lack of interest in participating in a gardening program
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 |
|---|---|---|
| Homestead Food Production programAlso: Agriculture, Home gardening, Nutrition educationTraining and support for vegetable gardening and poultry rearing, and education on young child nutrition, hygiene and health topics, in women's groups, as designed by the international non-governmental organization (NGO) Helen Keller International (HKI). | Behavioural | Homestead Food Production |
Primary outcome
Linear growth in children below 3 years of age
Time frame: Measured 50 months after randomization (endline survey 2019)
Length/height-for-age Z-score
20 secondary outcomes
Linear growth in children aged 6-30 months
Time frame: Measured 50 months after randomization
Intrauterine growth retardation: length
Time frame: Measured within 3 days of birth, 15-57 months after randomization
Intrauterine growth retardation: small-for-gestational age
Time frame: Measured within 3 days of birth, 15-57 months after randomization
Intrauterine growth retardation: head size
Time frame: Measured within 3 days of birth, 15-57 months after randomization
Wasting in children below 3 years of age
Time frame: Measured 50 months after randomization
Head circumference in children below 3 years of age
Time frame: Measured 50 months after randomization
Underweight in women
Time frame: Measured 50 months after randomization
Gestational weight gain
Time frame: Measured every 2 months during pregnancy, 6-57 months after randomization
Anemia in women and children below 3 years of age
Time frame: Measured 50 months after randomization
Micronutrients: Vitamin A deficiency in women and in children below 3 years of age
Time frame: Measured 50 months after randomization
Micronutrients: Iron deficiency in women and in children below 3 years of age
Time frame: Measured 50 months after randomization
Micronutrients: Zinc deficiency in women and in children below 3 years of age
Time frame: Measured 50 months after randomization
Early child development (adapted WHO milestones)
Time frame: Measured at appropriate ages for milestones, 6-50 months after randomization
Diarrhea in children below 3 years of age
Time frame: Measured every 2 months, 6-50 months after randomization
Acute respiratory infection in children below 3 years of age
Time frame: Measured every 2 months, 6-50 months after randomization
Enteropathy in children below 18 months of age
Time frame: Measured 36 and 50 months after randomization
Dietary adequacy in women and children below 3 years of age
Time frame: Measured every 2 months, 6-50 months after randomization
Dietary diversity in women and children below 3 years of age
Time frame: Measured every 2 months, 6-50 months after randomization
Fecal contamination of complementary food for children 6-18 months of age
Time frame: Measured 36 months after randomization
Food hygiene behaviour in mothers of children aged 6-18 months
Time frame: Measured 36 months after randomization
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 18 May 2022.
- Derived from this study: PubMed 42086300Sparling TM, Cornejo C, Offner C, Mayer A, Waid JL, Kadiyala S, Gabrysch S. Nutrition-sensitive agriculture programme impacts women's mental health via food security in rural Bangladesh. BMJ Glob Health. 2026 May 5;11(5):e020509. doi: 10.1136/bmjgh-2025-020509.
- Derived from this study: PubMed 40387380Wendt AS, Waid JL, Muller-Hauser AA, Lambrecht NJ, Huda TMN, Kyei NNA, Gabrysch S. Impacts of a Homestead Food Production Intervention on Anaemia and Micronutrient Deficiencies Among Women and Children in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Matern Child Nutr. 2025 Oct;21(4):e70043. doi: 10.1111/mcn.70043. Epub 2025 May 19.
- Derived from this study: PubMed 37983985Sobhan S, Muller-Hauser AA, Gon G, Nurul Huda TM, Waid JL, Wendt AS, Rahman M, Gabrysch S. Effect of a behaviour change intervention on household food hygiene practices in rural Bangladesh: A cluster-randomised controlled trial. Int J Hyg Environ Health. 2024 Jan;255:114291. doi: 10.1016/j.ijheh.2023.114291. Epub 2023 Nov 18.
- Derived from this study: PubMed 37871747Waid JL, Wendt AS, Kader A, Sobhan S, Gabrysch S. Impact of a Homestead Food Production Program on Dietary Diversity: Seasonal and Annual Results from the Cluster-Randomized FAARM Trial in Sylhet, Bangladesh. J Nutr. 2024 Jan;154(1):191-201. doi: 10.1016/j.tjnut.2023.10.014. Epub 2023 Oct 21.
- Derived from this study: PubMed 37783459Muller-Hauser AA, Huda TMN, Sobhan S, Lambrecht NJ, Waid JL, Wendt AS, Ali S, Rahman M, Gabrysch S. Effect of a Homestead Food Production and Food Hygiene Intervention on Biomarkers of Environmental Enteric Dysfunction in Children Younger Than 24 Months in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Oct 2;109(5):1166-1176. doi: 10.4269/ajtmh.23-0153. Print 2023 Nov 1.
- Derived from this study: PubMed 37580032Lambrecht NJ, Muller-Hauser AA, Sobhan S, Schmidt WP, Huda TMN, Waid JL, Wendt AS, Kader A, Gabrysch S. Effect of a Homestead Food Production Program on the Prevalence of Diarrhea and Acute Respiratory Infection in Children in Sylhet, Bangladesh: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2023 Aug 14;109(4):945-956. doi: 10.4269/ajtmh.23-0152. Print 2023 Oct 4.
- Derived from this study: PubMed 35045859Dupuis S, Hennink M, Wendt AS, Waid JL, Kalam MA, Gabrysch S, Sinharoy SS. Women's empowerment through homestead food production in rural Bangladesh. BMC Public Health. 2022 Jan 19;22(1):134. doi: 10.1186/s12889-022-12524-2.
- Derived from this study: PubMed 31620671Wendt AS, Waid JL, Gabrysch S. Dietary Factors Moderate the Relation between Groundwater Iron and Anemia in Women and Children in Rural Bangladesh. Curr Dev Nutr. 2019 Aug 6;3(10):nzz093. doi: 10.1093/cdn/nzz093. eCollection 2019 Oct.
- Derived from this study: PubMed 31278109Wendt AS, Sparling TM, Waid JL, Mueller AA, Gabrysch S. Food and Agricultural Approaches to Reducing Malnutrition (FAARM): protocol for a cluster-randomised controlled trial to evaluate the impact of a Homestead Food Production programme on undernutrition in rural Bangladesh. BMJ Open. 2019 Jul 4;9(7):e031037. doi: 10.1136/bmjopen-2019-031037.
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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.
Sabine Gabrysch, MD MSc PhD principal investigator
Heidelberg University
Questions about this trial
What is this clinical trial studying?
A study testing Homestead Food Production program in people with Malnutrition, run by Sabine Gabrysch.
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 11 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: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Linear growth in children below 3 years of age (time frame: Measured 50 months after randomization (endline survey 2019)). 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 NCT02505711, which also lists 9 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 18 May 2022.