An interventional study of Multiple biofortified food crops (MBFC-Exp) and Commercially available non-fortified food crops (MBFC-C) in Vitamin A Deficiency, Iron Deficiency and Zinc Deficiency, sponsored by Cornell University. Active, not recruiting at 2 sites in India. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2023-05-26.
Sponsored by Cornell University · Not applicable, Interventional, and Other
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.
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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Cornell University is the lead sponsor of 103 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children: Age 6 to 24 months (at enrollment);
Mothers: Biological mothers of included children.
Exclusion Criteria
Children
Mothers
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The MBFC-Exp (Multiple biofortified food crops - Experimental) arm will consume meals based on biofortified food crops.
Other: Multiple biofortified food crops (MBFC-Exp)
The MBFC-C (Multiple biofortified food crops - Control) arm will consume the same meals based on non-biofortified (commercially available) food crops.
Other: Commercially available non-fortified food crops (MBFC-C)
Meals from three biofortified food crops will be consumed by children (and potentially their lactating mothers) three times per day, six days per week, for 9 months.
Also known as: Biofortified food crops
This arm will consume meals based on three commercially available (non-biofortified) food crops three times per day, six days per week, for 9 months.
Also known as: Non-biofortified food crops
Biomarkers of vitamin A, iron, and zinc status
Determined by serum ferritin (ng/mL) after nine months' intervention.
Time frame: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.
Time frame: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by serum retinol (µmol/L) after nine months' intervention.
Time frame: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by serum zinc (mcg/mL) after nine months' intervention.
Time frame: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.
Time frame: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by hemoglobin (g/dL) after nine months' intervention.
Time frame: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by hepcidin (ng/mL) after nine months' intervention.
Time frame: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by CRP (mg/L) after nine months' intervention.
Time frame: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by AGP (mg/L) after nine months' intervention.
Time frame: endline (9 months)
Physical growth
As determined by length/height (cm) after nine months' intervention.
Time frame: endline (9 months)
Physical growth
As determined by weight (kg) after nine months' intervention.
Time frame: endline (9 months)
Physical growth
As determined by head circumference (cm) after nine months' intervention.
Time frame: endline (9 months)
Physical growth
As determined by mid-upper arm circumference (mm) after nine months' intervention.
Time frame: endline (9 months)
Immune function
As assessed by cytokines and vaccine response after 9 months of intervention.
Time frame: endline (9 months)
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2019 to primary completion in Jan 2021, 22 months.
Of 19 interventional studies with no phase under Vitamin A Deficiency, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 22 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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