Clinical trial NCT02648893: Effect Of Multiple Biofortified Food Crops On Micronutrient Status And Immune Function Among Indian Infants and Their Mothers
Official title: Effect Of Delivering Micronutrients Through Multiple Biofortified Food Crops On Nutritional Status And Immune Function: A Feeding Trial In The First 1000 Days Of Life In India
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitamin A Deficiency
Iron Deficiency
Zinc Deficiency
Keywords: iron
zinc
vitamin A
biofortified
efficacy
India
infant
trial
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: SNDT Women's University
name: Arogyavaram Medical Centre
First posted: 2016-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, meals based on multiple food crops (containing either biofortified or commercially-available food crops) will be fed to young children in Madanapalle, Andhra Pradesh, India over a period of nine months to measure growth, cognitive changes, and immune function in comparison to children receiving non-biofortified crops. Mothers of the participating children will also be included in the study.

Detailed description: Iron, zinc, and vitamin A deficiency remain a major worldwide public health problem especially in developing countries such as India. In this randomized study, 200 children aged 6-12 months (and their lactating mothers) from Madanapalle, Andhra Pradesh, India will be fed meals based on (either biofortified or commercially-available) multiple food crops three times per day, six days per week, for nine months. We will recruit children from 6 - 24 months of age. The goal of this study is to examine the effects of the biofortified multiple food crops on immune function, growth, and cognitive function in this age group. The key outcome measures are biomarkers of vitamin A, iron and zinc status, growth (anthropometric z-scores), and immune and cognitive function. Nutrient biomarkers 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, multiple specific aspects of memory and attention 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. In addition, the Development Assessment Scales for Indian Infants (DASII) test will be conducted at baseline, intermediate, and endline assessments to obtain a broad measure of attainment of developmental milestones that can be used to compare the characteristics of this cohort with those reported in the literature.

Eligibility criteria: Inclusion Criteria

Children: Age 6 to 24 months (at enrollment);

Mothers: Biological mothers of included children.

Exclusion Criteria

Children

* Age below 6 months or above 24 months (at time of screening);
* Hemoglobin \<9 g/dL (at time of screening);
* Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score \< -3);
* Prior known or current diagnoses of HIV/AIDS, Malaria, Dengue fever, Tuberculosis;
* Children whose biological mother is unable to bring her/him to feeding center daily;
* Possibility of migrating out of the study catchment area for more than 4 consecutive weeks;
* Prior or current consumption of iron, zinc, and/or vitamin A supplements;
* Any known dietary allergies.

Mothers

- Severe anemia (Hemoglobin \<7g/ dL)

Primary outcomes:
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Biomarkers of vitamin A, iron, and zinc status
timeFrame: endline (9 months)
measure: Physical growth
timeFrame: endline (9 months)
measure: Physical growth
timeFrame: endline (9 months)
measure: Physical growth
timeFrame: endline (9 months)
measure: Physical growth
timeFrame: endline (9 months)
measure: Immune function
timeFrame: endline (9 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Madanapalle
country: India
facility: Arogyavaram Medical Centre
city: Mumbai
country: India
facility: S.N.D.T. Women's University
Study officials:
affiliation: Cornell University
name: Saurabh Mehta, MBBS, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Julia L. Finkelstein, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: SNDT Women's University
name: Shobha Udipi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arogyavaram Medical Centre
name: Bonam Wesley, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Jere D Haas, PhD
role: PRINCIPAL_INVESTIGATOR
References: