CompletedNot Applicable

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

India223 participantsStarted 2017-05-08

Plain-language 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.

Who can participate

Age range

12 Months – 18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hemoglobin (g/dL)

Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Hemoglobin (g/dL)

Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Iron Status

Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Iron Status

Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Iron Status BRINDA Adjusted

Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Iron Status BRINDA Adjusted

Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Trial details

NCT IDNCT02233764

SponsorCornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-16

Results submitted2023-03-02

View on ClinicalTrials.gov More Iron Deficiency trials

Who can participate

Age range

12 Months – 18 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Hemoglobin (g/dL)

Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Hemoglobin (g/dL)

Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Iron Status

Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Iron Status

Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Iron Status BRINDA Adjusted

Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)

Iron Status BRINDA Adjusted

Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)