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

Iron Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233764
• Other study ID #: IRB #: 1403004556
• Status: Completed
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: July 16, 2018

Study information

• Verified date: January 2019
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 growth and immune function in comparison to children receiving non-biofortified pearl millet.

Description:

Iron and zinc deficiency remain a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 700 children aged 12-18 months from Mumbai, Maharashtra, India will be 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 is to examine the effects of iron and zinc biofortified millet on immune function, growth, and cognitive function in this age group. The key outcome measures are biomarkers of iron and zinc status, growth, and immune function. Serum concentrations of hemoglobin, ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha 1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To assess cognitive function in a subset, multiple specific aspects of memory, attention, and processing speed will be assessed. Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency
• Zinc Deficiency

Intervention

Other:
• FeZnPM
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.
• CtrlPM
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.

Locations

Country	Name	City	State
India	St. John's Research Institute	Karnataka
India	Centre for the Study of Social Change-Mumbai	Mumbai	Maharashtra
India	S.N.D.T. Women's University	Mumbai

Sponsors (4)

Lead Sponsor	Collaborator
Cornell University	Center for the Study of Social Change, SNDT Women's University, St. John's Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function	Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.	Midline serial assessment/sample between months 2-7, in a subset
Other	Cognitive function	Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.	Endline (nine months) in a subset
Primary	Iron status	Determined by serum ferritin, sTfR, and total body iron	Midline serial assessment/sample between months 2-7
Primary	Iron status	Determined by serum ferritin, sTfR, and total body iron	Endline (nine months)
Primary	Physical growth	As determined by length/height, weight, head circumference, and mid-upper arm circumference.	Midline serial assessment/sample between months 2-7
Primary	Physical growth	As determined by length/height, weight, head circumference, and mid-upper arm circumference.	Endline (nine months)
Primary	Immune function	Measurement of T cell counts and vaccine response ELISA assays.	1 Midline serial assessment/sample between months 2-7
Primary	Immune function	Measurement of T cell counts and vaccine response ELISA assays.	Endline (nine months)