Iron DeficiencyNCT02233764

Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India

A study testing FeZnPM and CtrlPM in people with Iron Deficiency and Zinc Deficiency, run by Cornell University at 3 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure iron status, growth and immune function in comparison to children receiving non-biofortified pearl millet. Read more about this study

Who is it for?: Ages 12 to 18 months
Conditions the study is for: Iron Deficiency, Zinc Deficiency
What is being tested?: FeZnPM and CtrlPM
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 223 participants
Where: 3 sitesIndia
Study dates: 8 May 2017to 16 Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 18 months
All sexes
No healthy volunteers
Child

Who may be able to join

Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
Hemoglobin ≥9 g/dL

Who cannot join

Age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit)
Hemoglobin < 9 g/dL and/or hemoglobinopathy
Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3)
Prior diagnoses of HIV/AIDS or Tuberculosis, or Current diagnosis of HIV/AIDS, malaria, Dengue fever, Tuberculosis requiring >1 day hospitalization
Children who do not have a caretaker to bring him/her to feeding center
Possibility of migrating out of the slum dwelling for longer than 4 weeks
Prior or current consumption of iron or zinc supplements in the past 1 year
Any known dietary allergies

Trial locations and contacts

3 sites in 1 country.

India3 sites

St. John's Research Institute
Bengaluru, Karnataka, 560 034
Centre for the Study of Social Change-Mumbai
Mumbai, Maharashtra, 400 051
S.N.D.T. Women's University
Mumbai, 400049

Other trials in India

About this study

Official title: Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India

Read the detailed description

Iron deficiency remains a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 223 children aged 12-18 months from Mumbai, Maharashtra, India were fed either iron and zinc-biofortified pearl millet or control pearl millet three times per day, six days per week, for nine months. The goal of this study was to examine the effects of iron and zinc-biofortified millet on markers of iron status, growth, and immune function in this age group. The key outcome measures were biomarkers of iron status, physical growth, and immune function defined as response to measles vaccine. Concentrations of serum ferritin and hemoglobin as well as markers of immune function were assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endpoint). Additionally, we measured concentrations of C-reactive protein (CRP), as iron biomarkers can be influenced by inflammation. Growth was assessed monthly for 9 months and expressed as anthropometric Z-scores.

Conditions: Iron Deficiency, Zinc Deficiency
Being tested: FeZnPM, CtrlPM
Keywords: iron, zinc, pearl millet, India, children, trial, randomized
Medical subject headings: Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FeZnPMOther
Also called biofortified pearl millet, bajra, ICTP8203-Fe
Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPMOther
Also called bajra, pearl millet
Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.

Study groups in NCT02233764
Study group	Role	What they receive
FeZnPM	Experimental	The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe). Receives: Other: FeZnPM
CtrlPM	Active comparator	The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits. Receives: Other: CtrlPM

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin (g/dL)
As determined by hemoglobin concentration
Measured: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Hemoglobin (g/dL)
As determined by hemoglobin concentration
Measured: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status
Determined by serum ferritin
Measured: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status
Determined by serum ferritin
Measured: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status BRINDA Adjusted
Determined by serum ferritin BRINDA adjusted
Measured: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status BRINDA Adjusted
Serum ferritin BRINDA adjusted
Measured: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth
Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age).
Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards.
Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Measured: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth
Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age).
Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards.
Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Measured: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth
Full scale name: Weight-for-age Z-score (child's body weight as compared to their age).
Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards.
Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.
Measured: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth
Full scale name: Weight-for-age Z-score (child's body weight as compared to their age).
Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards.
Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.
Measured: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune Function
Immune responses primarily defined as protective anti-measles IgG titers (>16.5 AU/mL).
Measured: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune Function
Immune responses primarily defined as response to measles vaccine
Measured: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 201716 Jul 2018

First posted8 Sep 2014 (estimated)
Study start8 May 2017
Primary completion16 Jul 2018
Study completion16 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Iron DeficiencyStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02233764
Sponsor's protocol ID: IRB #: 1403004556
Status last verified: Feb 2026
First submitted: 4 Sep 2014
Last updated: 9 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Mehta S, Finkelstein JL, Venkatramanan S, Huey SL, Udipi SA, Ghugre P, Ruth C, Canfield RL, Kurpad AV, Potdar RD, Haas JD. Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12-18 months in India: study protocol for a randomised controlled trial. BMJ Open. 2017 Nov 14;7(11):e017631. doi: 10.1136/bmjopen-2017-017631.
PubMed 29138201
Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12 to 18 months living in urban slums. Clin Nutr. 2022 Apr;41(4):937-947. doi: 10.1016/j.clnu.2022.02.014. Epub 2022 Feb 24.
PubMed 35299084
Huey SL, Cole NL, Pagani I, Gonzalez A, Finkelstein JL, Haas JD, Udipi SA, Ghugre P, Potdar RD, Knight R, Mehta S. Effect of a complementary feeding intervention based on iron- and zinc-biofortified pearl millet on the gut microbiota in 12-18-month-old children: a randomized trial. Nat Commun. 2026 Jul 30;17(1):9242. doi: 10.1038/s41467-026-75674-6.
PubMed 42669658
Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Rajagopalan K, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12-18 months living in urban slums. Clin Nutr. 2026 Apr;59:106517. doi: 10.1016/j.clnu.2025.11.002. Epub 2026 Feb 9.
PubMed 41740296
Huey SL, Finkelstein JL, Venkatramanan S, Udipi SA, Ghugre P, Thakker V, Thorat A, Potdar RD, Chopra HV, Kurpad AV, Haas JD, Mehta S. Prevalence and Correlates of Undernutrition in Young Children Living in Urban Slums of Mumbai, India: A Cross Sectional Study. Front Public Health. 2019 Jul 12;7:191. doi: 10.3389/fpubh.2019.00191. eCollection 2019.
PubMed 31355176
Huey SL, Venkatramanan S, Udipi SA, Finkelstein JL, Ghugre P, Haas JD, Thakker V, Thorat A, Salvi A, Kurpad AV, Mehta S. Acceptability of Iron- and Zinc-Biofortified Pearl Millet (Dhanashakti)-Based [corrected] Complementary Foods among Children in an Urban Slum of Mumbai, India. Front Nutr. 2017 Aug 25;4:39. doi: 10.3389/fnut.2017.00039. eCollection 2017.
PubMed 28971097

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
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RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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All Iron Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India
ClinicalTrials.gov ID: NCT02233764
Acronym / sponsor ID: IRB #: 1403004556
Conditions: Iron Deficiency, Zinc Deficiency
Keywords: iron, zinc, pearl millet, India, children, trial, randomized
Study type: Interventional
Recruitment status: Completed
Enrolment: 223 participants (actual)
Lead sponsor: Cornell UniversityUniversity, hospital or other
Collaborators: SNDT Women's University, St. John's Research Institute, Center for the Study of Social Change
Study start: 8 May 2017 (actual)
Primary completion: 16 Jul 2018 (actual)
Study completion: 16 Jul 2018 (actual)
First posted: 8 Sep 2014 (estimated)
Results: Posted 9 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
FeZnPM	Experimental	Other: FeZnPMThe FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
CtrlPM	Active comparator	Other: CtrlPMThe CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.

Who may qualify

Ages: 12 to 18 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
Hemoglobin ≥9 g/dL

Key exclusion criteria (8 listed)

Age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit)
Hemoglobin < 9 g/dL and/or hemoglobinopathy
Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score < -3)
Prior diagnoses of HIV/AIDS or Tuberculosis, or Current diagnosis of HIV/AIDS, malaria, Dengue fever, Tuberculosis requiring >1 day hospitalization
Children who do not have a caretaker to bring him/her to feeding center

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
FeZnPMAlso: biofortified pearl millet, bajra, ICTP8203-FeIron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.	Other	FeZnPM
CtrlPMAlso: bajra, pearl milletConventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.	Other	CtrlPM

Primary outcome

Hemoglobin (g/dL)
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
As determined by hemoglobin concentration
Hemoglobin (g/dL)
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
As determined by hemoglobin concentration
Iron Status
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Determined by serum ferritin
Iron Status
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Determined by serum ferritin
Iron Status BRINDA Adjusted
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Determined by serum ferritin BRINDA adjusted
Iron Status BRINDA Adjusted
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Serum ferritin BRINDA adjusted
Physical Growth
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Physical Growth
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Physical Growth
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Full scale name: Weight-for-age Z-score (child's body weight as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.
Physical Growth
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Full scale name: Weight-for-age Z-score (child's body weight as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.
Immune Function
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune responses primarily defined as protective anti-measles IgG titers (>16.5 AU/mL).
Immune Function
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune responses primarily defined as response to measles vaccine

Results and safety

Results posted to the registry on 9 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FeZnPM	112	90
CtrlPM	111	90

Primary outcome: Hemoglobin (g/dL)

Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline). Median (Inter-Quartile Range). Unit: g/dL

Measure	FeZnPM n = 69	CtrlPM n = 63
Value	10.90 (10.00 to 11.40)	10.30 (9.60 to 11.10)

Primary outcome: Hemoglobin (g/dL)

Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline). Median (Inter-Quartile Range). Unit: g/dL

Measure	FeZnPM n = 69	CtrlPM n = 63
Value	0.10 (-0.60 to 0.90)	-0.20 (-1.10 to 0.50)

Primary outcome: Iron Status

Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline). Median (Inter-Quartile Range). Unit: µg/L

Measure	FeZnPM n = 68	CtrlPM n = 61
Value	-1.65 (-7.70 to 2.20)	-2.50 (-7.20 to -0.20)

Primary outcome: Iron Status

Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline). Median (Inter-Quartile Range). Unit: µg/L

Measure	FeZnPM n = 70	CtrlPM n = 63
Value	7.30 (3.60 to 12.10)	4.70 (2.80 to 11.80)

Adverse events

Time frame: Up to 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FeZnPM	0 of 112 (0%)	0 of 112 (0%)	0 of 112
CtrlPM	0 of 111 (0%)	0 of 111 (0%)	0 of 111

Limitations and caveats (from the sponsor): Given the urban slum context of this study, participants missed days of feeding and/or were lost to follow-up due to several reasons (see Mehta et al. 2022). Collecting enough whole blood from participants was difficult due to low blood volume, and equipment able to perform multiple assays with limited blood volume was unavailable locally. Tests for primary endpoints were prioritized based on available sample volume and some tests therefore could only be conducted in a subset of samples.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29138201Mehta S, Finkelstein JL, Venkatramanan S, Huey SL, Udipi SA, Ghugre P, Ruth C, Canfield RL, Kurpad AV, Potdar RD, Haas JD. Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12-18 months in India: study protocol for a randomised controlled trial. BMJ Open. 2017 Nov 14;7(11):e017631. doi: 10.1136/bmjopen-2017-017631.
Results publication: PubMed 35299084Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12 to 18 months living in urban slums. Clin Nutr. 2022 Apr;41(4):937-947. doi: 10.1016/j.clnu.2022.02.014. Epub 2022 Feb 24.
Derived from this study: PubMed 42669658Huey SL, Cole NL, Pagani I, Gonzalez A, Finkelstein JL, Haas JD, Udipi SA, Ghugre P, Potdar RD, Knight R, Mehta S. Effect of a complementary feeding intervention based on iron- and zinc-biofortified pearl millet on the gut microbiota in 12-18-month-old children: a randomized trial. Nat Commun. 2026 Jul 30;17(1):9242. doi: 10.1038/s41467-026-75674-6.
Derived from this study: PubMed 41740296Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Rajagopalan K, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12-18 months living in urban slums. Clin Nutr. 2026 Apr;59:106517. doi: 10.1016/j.clnu.2025.11.002. Epub 2026 Feb 9.
Derived from this study: PubMed 31355176Huey SL, Finkelstein JL, Venkatramanan S, Udipi SA, Ghugre P, Thakker V, Thorat A, Potdar RD, Chopra HV, Kurpad AV, Haas JD, Mehta S. Prevalence and Correlates of Undernutrition in Young Children Living in Urban Slums of Mumbai, India: A Cross Sectional Study. Front Public Health. 2019 Jul 12;7:191. doi: 10.3389/fpubh.2019.00191. eCollection 2019.
Derived from this study: PubMed 28971097Huey SL, Venkatramanan S, Udipi SA, Finkelstein JL, Ghugre P, Haas JD, Thakker V, Thorat A, Salvi A, Kurpad AV, Mehta S. Acceptability of Iron- and Zinc-Biofortified Pearl Millet (Dhanashakti)-Based [corrected] Complementary Foods among Children in an Urban Slum of Mumbai, India. Front Nutr. 2017 Aug 25;4:39. doi: 10.3389/fnut.2017.00039. eCollection 2017.

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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.

Saurabh Mehta, MBBS, ScD principal investigator

Cornell University

Jere D. Haas, Ph.D. principal investigator

Cornell University

Julia L. Finkelstein, Sc.D. principal investigator

Cornell University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FeZnPM and CtrlPM in people with Iron Deficiency and Zinc Deficiency, run by Cornell University at 3 sites in India.

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 2 inclusion and 8 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 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India. 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?

Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hemoglobin (g/dL) (time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)). The study lists 12 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 NCT02233764, 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 9 Mar 2026.