Iron Deficiency, Zinc Deficiency
Conditions
Keywords
iron, zinc, pearl millet, India, children, trial, randomized
Brief 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.
Detailed description
Iron deficiency remains a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 223 children aged 12-18 months from Mumbai, Maharashtra, India were 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 was to examine the effects of iron and zinc-biofortified millet on markers of iron status, growth, and immune function in this age group. The key outcome measures were biomarkers of iron status, physical growth, and immune function defined as response to measles vaccine. Concentrations of serum ferritin and hemoglobin as well as markers of immune function were assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endpoint). Additionally, we measured concentrations of C-reactive protein (CRP), as iron biomarkers can be influenced by inflammation. Growth was assessed monthly for 9 months and expressed as anthropometric Z-scores.
Interventions
OTHERFeZnPM
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.
OTHERCtrlPM
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.
Sponsors
Cornell University
SNDT Women's University
St. John's Research Institute
Center for the Study of Social Change
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin (g/dL) | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) | As determined by hemoglobin concentration |
| Iron Status | Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) | Determined by serum ferritin |
| Iron Status BRINDA Adjusted | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) | Determined by serum ferritin BRINDA adjusted |
| Physical Growth | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) | Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting. |
| Immune Function | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) | Immune responses primarily defined as protective anti-measles IgG titers (\>16.5 AU/mL). |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORSaurabh Mehta, MBBS, ScD
Cornell University
PRINCIPAL_INVESTIGATORJere D. Haas, Ph.D.
Cornell University
PRINCIPAL_INVESTIGATORJulia L. Finkelstein, Sc.D.
Cornell University
PRINCIPAL_INVESTIGATORRichard L. Canfield, Ph.D.
Cornell University
PRINCIPAL_INVESTIGATORShobha Udipi, Ph.D.
SNDT Women's University
PRINCIPAL_INVESTIGATORPadmini Ghugre
SNDT Women's University
PRINCIPAL_INVESTIGATORR. Potdar
Centre for the Study of Social Change-Mumbai
PRINCIPAL_INVESTIGATORAnura Kurpad
St. John's Research Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 223 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 14.4 months |
| Iron status | 10.5 g/dL |
| Iron Status BRINDA Adjusted | 6.2 µg/L |
| Physical Growth | -1.3 z-score |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 111 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 111 |
| other Total, other adverse events | 0 / 112 | 0 / 111 |
| serious Total, serious adverse events | 0 / 112 | 0 / 111 |
Outcome results
None listed