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 range12 Months – 18 Months

SexALL

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

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)

Physical Growth

Timeframe: 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 range12 Months – 18 Months

SexALL

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)

Physical Growth

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