An interventional study of FeZnPM and CtrlPM in Iron Deficiency and Zinc Deficiency, sponsored by Cornell University. Completed at 3 sites in India. Open to participants aged 12 Months to 18 Months. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Cornell University · Not applicable, Interventional, and Other
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.
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.
772 studies on the registry are indexed under Iron Deficiencies; 115 are open to participants now.
This study's enrollment of 223 is above the median of 100 across 592 interventional studies indexed under Iron Deficiencies.
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Exclusion Criteria:
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
Other: FeZnPM
The CtrlPM arm will consume conventional pearl millet 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.
Other: CtrlPM
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.
Also known as: biofortified pearl millet, bajra, ICTP8203-Fe
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.
Also known as: bajra, pearl millet
Hemoglobin (g/dL)
As determined by hemoglobin concentration
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Hemoglobin (g/dL)
As determined by hemoglobin concentration
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status
Determined by serum ferritin
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status
Determined by serum ferritin
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status BRINDA Adjusted
Determined by serum ferritin BRINDA adjusted
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Iron Status BRINDA Adjusted
Serum ferritin BRINDA adjusted
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth
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.
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth
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.
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth
Full scale name: Weight-for-age Z-score (child's body weight 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 underweight.
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Physical Growth
Full scale name: Weight-for-age Z-score (child's body weight 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 underweight.
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune Function
Immune responses primarily defined as protective anti-measles IgG titers (\>16.5 AU/mL).
Time frame: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Immune Function
Immune responses primarily defined as response to measles vaccine
Time frame: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
| Milestone | FeZnPM | CtrlPM |
|---|---|---|
| Started | 112 | 111 |
| Completed | 90 | 90 |
| Not completed | 22 | 21 |
As determined by hemoglobin concentration
| g/dL | FeZnPM | CtrlPM |
|---|---|---|
| Hemoglobin (g/dL) | 10.90 (10.00 to 11.40) | 10.30 (9.60 to 11.10) |
As determined by hemoglobin concentration
| g/dL | FeZnPM | CtrlPM |
|---|---|---|
| Hemoglobin (g/dL) | 0.10 (-0.60 to 0.90) | -0.20 (-1.10 to 0.50) |
Determined by serum ferritin
| µg/L | FeZnPM | CtrlPM |
|---|---|---|
| Iron Status | -1.65 (-7.70 to 2.20) | -2.50 (-7.20 to -0.20) |
Determined by serum ferritin
| µg/L | FeZnPM | CtrlPM |
|---|---|---|
| Iron Status | 7.30 (3.60 to 12.10) | 4.70 (2.80 to 11.80) |
Determined by serum ferritin BRINDA adjusted
| µg/L | FeZnPM | CtrlPM |
|---|---|---|
| Iron Status BRINDA Adjusted | 5.27 (2.99 to 8.74) | 3.62 (2.11 to 8.69) |
Serum ferritin BRINDA adjusted
| µg/L | FeZnPM | CtrlPM |
|---|---|---|
| Iron Status BRINDA Adjusted | -1.27 (-6.34 to 1.37) | -1.99 (-5.78 to 0.04) |
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.
| z score | FeZnPM | CtrlPM |
|---|---|---|
| Physical Growth | -1.6 (-2.3 to -0.8) | -1.5 (-2.3 to -0.9) |
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.
| z score | FeZnPM | CtrlPM |
|---|---|---|
| Physical Growth | -0.2 (-0.6 to 0.2) | -0.2 (-0.6 to 0.2) |
Full scale name: Weight-for-age Z-score (child's body weight 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 underweight.
| z score | FeZnPM | CtrlPM |
|---|---|---|
| Physical Growth | -1.5 (-2.1 to -0.8) | -1.6 (-2.2 to -0.5) |
Full scale name: Weight-for-age Z-score (child's body weight 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 underweight.
| z score | FeZnPM | CtrlPM |
|---|---|---|
| Physical Growth | -0.2 (-0.6 to 0.0) | -0.2 (-0.5 to 0.0) |
Immune responses primarily defined as protective anti-measles IgG titers (\>16.5 AU/mL).
| Participants | FeZnPM | CtrlPM |
|---|---|---|
| Immune Function | 56 | 46 |
Immune responses primarily defined as response to measles vaccine
| AU/mL | FeZnPM | CtrlPM |
|---|---|---|
| Immune Function | 23.08 (-9.90 to 79.53) | 0.74 (-12.44 to 37.00) |
Collected over Up to 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FeZnPM | 0/112 (0%) | 0/112 (0%) | 0/112 (0%) |
| CtrlPM | 0/111 (0%) | 0/111 (0%) | 0/111 (0%) |
| Age, Categorical(Participants) | FeZnPM | CtrlPM | Total |
|---|---|---|---|
| <=18 years | 112 | 111 | 223 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(months) | FeZnPM | CtrlPM | Total |
|---|---|---|---|
| Median | 14.4 (12.7 to 17.0) | 14.9 (13.1 to 16.7) | 14.6 (12.8 to 16.7) |
| Sex: Female, Male(Participants) | FeZnPM | CtrlPM | Total |
|---|---|---|---|
| Female | 59 | 57 | 116 |
| Male | 53 | 54 | 107 |
| Race (NIH/OMB)(Participants) | FeZnPM | CtrlPM | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 112 | 111 | 223 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Iron status(µg/L) | FeZnPM | CtrlPM | Total |
|---|---|---|---|
| Median | 8.5 (4.3 to 18.2) | 8.4 (4.4 to 15.7) | 8.4 (4.4 to 16.6) |
| Physical Growth(z-score) | FeZnPM | CtrlPM | Total |
|---|---|---|---|
| Median | -1.3 (-2.1 to -0.6) | -1.4 (-2.0 to -0.7) | -1.3 (-2.1 to -0.6) |
| Iron Status BRINDA Adjusted(µg/L) | FeZnPM | CtrlPM | Total |
|---|---|---|---|
| Median | 6.3 (3.3 to 14.0) | 5.9 (3.5 to 16.7) | 6.2 (3.5 to 12.8) |
| Physical Growth(z-score) | FeZnPM | CtrlPM | Total |
|---|---|---|---|
| Median | -1.2 (-2.0 to -0.5) | -1.4 (-2.0 to -0.5) | -1.3 (-2.0 to -0.5) |
1 further baseline measures are reported on the registry.
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