Vitamin A DeficiencyMBFCNCT02648893
Effect Of Multiple Biofortified Food Crops On Micronutrient Status And Immune Function Among Indian Infants and Their Mothers
A study testing Multiple biofortified food crops (MBFC-Exp) and Commercially available non-fortified food crops (MBFC-C) in people with Vitamin A Deficiency and Iron Deficiency, run by Cornell University at 2 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency
- What is being tested?
- Multiple biofortified food crops (MBFC-Exp) and Commercially available non-fortified food crops (MBFC-C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesIndia
- Study dates
- 28 Feb 2019to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children: Age 6 to 24 months (at enrollment);
- Mothers: Biological mothers of included children.
Who cannot join
- 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;
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- 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)
Trial locations and contacts
2 sites in 1 country.
India2 sites
Arogyavaram Medical Centre
Madanapalle
S.N.D.T. Women's University
Mumbai, 400049
About this study
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
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.
Read the 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.
- Conditions
- Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency
- Being tested
- Multiple biofortified food crops (MBFC-Exp), Commercially available non-fortified food crops (MBFC-C)
- Keywords
- iron, zinc, vitamin A, biofortified, efficacy, India, infant, trial
- Medical subject headings
- Vitamin A Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple biofortified food crops (MBFC-Exp)Other
Also called Biofortified food crops
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.
Commercially available non-fortified food crops (MBFC-C)Other
Also called Non-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.
| Study group | Role | What they receive |
|---|---|---|
| MBFC-Exp | Experimental | The MBFC-Exp (Multiple biofortified food crops - Experimental) arm will consume meals based on biofortified food crops. Receives: Other: Multiple biofortified food crops (MBFC-Exp) |
| MBFC-C | Active comparator | The MBFC-C (Multiple biofortified food crops - Control) arm will consume the same meals based on non-biofortified (commercially available) food crops. Receives: Other: Commercially available non-fortified food crops (MBFC-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of vitamin A, iron, and zinc status
Determined by serum ferritin (ng/mL) after nine months' intervention.
Measured: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.
Measured: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by serum retinol (µmol/L) after nine months' intervention.
Measured: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by serum zinc (mcg/mL) after nine months' intervention.
Measured: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.
Measured: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by hemoglobin (g/dL) after nine months' intervention.
Measured: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by hepcidin (ng/mL) after nine months' intervention.
Measured: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by CRP (mg/L) after nine months' intervention.
Measured: endline (9 months)
Biomarkers of vitamin A, iron, and zinc status
Determined by AGP (mg/L) after nine months' intervention.
Measured: endline (9 months)
Physical growth
As determined by length/height (cm) after nine months' intervention.
Measured: endline (9 months)
Physical growth
As determined by weight (kg) after nine months' intervention.
Measured: endline (9 months)
Physical growth
As determined by head circumference (cm) after nine months' intervention.
Measured: endline (9 months)
Physical growth
As determined by mid-upper arm circumference (mm) after nine months' intervention.
Measured: endline (9 months)
Immune function
As assessed by cytokines and vaccine response after 9 months of intervention.
Measured: endline (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start28 Feb 2019
- Primary completion13 Jan 2021
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- SNDT Women's University, Arogyavaram Medical Centre
- Responsible party
- Sponsor
- Investigators
- Saurabh Mehta, MBBS, ScD, Principal investigator, Cornell UniversityJulia L. Finkelstein, ScD, Principal investigator, Cornell UniversityShobha Udipi, PhD, Principal investigator, SNDT Women's UniversityBonam Wesley, MBBS, Principal investigator, Arogyavaram Medical CentreJere D Haas, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648893
- Sponsor's protocol ID
- IRB #: 1508005782
- Acronym
- MBFC
- Status last verified
- May 2023
- First submitted
- 23 Nov 2015
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02648893
- Acronym / sponsor ID
- MBFC / IRB #: 1508005782
- Conditions
- Vitamin A Deficiency, Iron Deficiency, Zinc Deficiency
- Keywords
- iron, zinc, vitamin A, biofortified, efficacy, India, infant, trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- SNDT Women's University, Arogyavaram Medical Centre
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBFC-Exp | Experimental | Other: Multiple biofortified food crops (MBFC-Exp)The MBFC-Exp (Multiple biofortified food crops - Experimental) arm will consume meals based on biofortified food crops. |
| MBFC-C | Active comparator | Other: Commercially available non-fortified food crops (MBFC-C)The MBFC-C (Multiple biofortified food crops - Control) arm will consume the same meals based on non-biofortified (commercially available) food crops. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children: Age 6 to 24 months (at enrollment);
- Mothers: Biological mothers of included children.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple biofortified food crops (MBFC-Exp)Also: Biofortified food cropsMeals 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. | Other | MBFC-Exp |
| Commercially available non-fortified food crops (MBFC-C)Also: Non-biofortified food cropsThis arm will consume meals based on three commercially available (non-biofortified) food crops three times per day, six days per week, for 9 months. | Other | MBFC-C |
Primary outcome
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by serum ferritin (ng/mL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by sTfR (soluble Transferrin Receptor; mg/L) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by serum retinol (µmol/L) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by serum zinc (mcg/mL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by RBP (Retinol-binding Protein; ng/mL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by hemoglobin (g/dL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by hepcidin (ng/mL) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by CRP (mg/L) after nine months' intervention.
Biomarkers of vitamin A, iron, and zinc status
Time frame: endline (9 months)
Determined by AGP (mg/L) after nine months' intervention.
Physical growth
Time frame: endline (9 months)
As determined by length/height (cm) after nine months' intervention.
Physical growth
Time frame: endline (9 months)
As determined by weight (kg) after nine months' intervention.
Physical growth
Time frame: endline (9 months)
As determined by head circumference (cm) after nine months' intervention.
Physical growth
Time frame: endline (9 months)
As determined by mid-upper arm circumference (mm) after nine months' intervention.
Immune function
Time frame: endline (9 months)
As assessed by cytokines and vaccine response after 9 months of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saurabh Mehta, MBBS, ScD principal investigator
Cornell University
Julia L. Finkelstein, ScD principal investigator
Cornell University
Shobha Udipi, PhD principal investigator
SNDT Women's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple biofortified food crops (MBFC-Exp) and Commercially available non-fortified food crops (MBFC-C) in people with Vitamin A Deficiency and Iron Deficiency, run by Cornell University at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of vitamin A, iron, and zinc status (time frame: endline (9 months)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.