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| Name | Class |
|---|---|
| SNDT Women's University | OTHER |
| St. John's Research Institute | OTHER |
| Center for the Study of Social Change | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FeZnPM | Experimental | The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe). |
|
| CtrlPM | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FeZnPM | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin (g/dL) | As determined by hemoglobin concentration | 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 | 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 | 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 | 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 | 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saurabh Mehta, MBBS, ScD | Cornell University | Principal Investigator |
| Jere D. Haas, Ph.D. | Cornell University | Principal Investigator |
| Julia L. Finkelstein, Sc.D. | Cornell University | Principal Investigator |
| Richard L. Canfield, Ph.D. | Cornell University | Principal Investigator |
| Shobha Udipi, Ph.D. | SNDT Women's University | Principal Investigator |
| Padmini Ghugre | SNDT Women's University | Principal Investigator |
| R. Potdar | Centre for the Study of Social Change-Mumbai | Principal Investigator |
| Anura Kurpad | St. John's Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Research Institute | Bengaluru | Karnataka | 560 034 | India | ||
| Centre for the Study of Social Change-Mumbai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29138201 | Background | Mehta S, Finkelstein JL, Venkatramanan S, Huey SL, Udipi SA, Ghugre P, Ruth C, Canfield RL, Kurpad AV, Potdar RD, Haas JD. Effect of iron and zinc-biofortified pearl millet consumption on growth and immune competence in children aged 12-18 months in India: study protocol for a randomised controlled trial. BMJ Open. 2017 Nov 14;7(11):e017631. doi: 10.1136/bmjopen-2017-017631. | |
| 35299084 |
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| ID | Title | Description |
|---|---|---|
| FG000 | FeZnPM | The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe). FeZnPM: 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. |
| FG001 | CtrlPM | 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. CtrlPM: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | FeZnPM | The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe). FeZnPM: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin (g/dL) | As determined by hemoglobin concentration | Posted | Median | Inter-Quartile Range | g/dL | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
|
Up to 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FeZnPM | The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe). FeZnPM: 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. |
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Given the urban slum context of this study, participants missed days of feeding and/or were lost to follow-up due to several reasons (see Mehta et al. 2022). Collecting enough whole blood from participants was difficult due to low blood volume, and equipment able to perform multiple assays with limited blood volume was unavailable locally. Tests for primary endpoints were prioritized based on available sample volume and some tests therefore could only be conducted in a subset of samples.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Saurabh Mehta | Cornell University | (607) 255-2640 | smehta@cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2017 | Jan 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| CtrlPM | Other | 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. |
|
|
| 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. | 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. | 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. | 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). | 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 | Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
| Mumbai |
| Maharashtra |
| 400 051 |
| India |
| S.N.D.T. Women's University | Mumbai | 400049 | India |
| Result |
| Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12 to 18 months living in urban slums. Clin Nutr. 2022 Apr;41(4):937-947. doi: 10.1016/j.clnu.2022.02.014. Epub 2022 Feb 24. |
| 41740296 | Derived | Mehta S, Huey SL, Ghugre PS, Potdar RD, Venkatramanan S, Krisher JT, Ruth CJ, Chopra HV, Thorat A, Thakker V, Johnson L, Powis L, Raveendran Y, Rajagopalan K, Haas JD, Finkelstein JL, Udipi SA; Project Sabal. A randomized trial of iron- and zinc-biofortified pearl millet-based complementary feeding in children aged 12-18 months living in urban slums. Clin Nutr. 2026 Apr;59:106517. doi: 10.1016/j.clnu.2025.11.002. Epub 2026 Feb 9. |
| 31355176 | Derived | Huey SL, Finkelstein JL, Venkatramanan S, Udipi SA, Ghugre P, Thakker V, Thorat A, Potdar RD, Chopra HV, Kurpad AV, Haas JD, Mehta S. Prevalence and Correlates of Undernutrition in Young Children Living in Urban Slums of Mumbai, India: A Cross Sectional Study. Front Public Health. 2019 Jul 12;7:191. doi: 10.3389/fpubh.2019.00191. eCollection 2019. |
| 28971097 | Derived | Huey SL, Venkatramanan S, Udipi SA, Finkelstein JL, Ghugre P, Haas JD, Thakker V, Thorat A, Salvi A, Kurpad AV, Mehta S. Acceptability of Iron- and Zinc-Biofortified Pearl Millet (Dhanashakti)-Based [corrected] Complementary Foods among Children in an Urban Slum of Mumbai, India. Front Nutr. 2017 Aug 25;4:39. doi: 10.3389/fnut.2017.00039. eCollection 2017. |
| BG001 | CtrlPM | 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. CtrlPM: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Iron status | serum ferritin | Children with available blood data were included in the analysis. | Median | Inter-Quartile Range | µg/L |
|
| Physical Growth | Length for Age Z-score | Median | Inter-Quartile Range | z-score |
|
| Iron Status BRINDA Adjusted | Serum ferritin adjusted for inflammation using the BRINDA method (Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia) using CRP only | Children with available blood data were included in the analysis. | Median | Inter-Quartile Range | µg/L |
|
| Physical Growth | Weight-for-age Z-score | Median | Inter-Quartile Range | z-score |
|
| Iron status | Hemoglobin concentration | Median | Inter-Quartile Range | g/dL |
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| Primary | Hemoglobin (g/dL) | As determined by hemoglobin concentration | Posted | Median | Inter-Quartile Range | g/dL | Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
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| Primary | Iron Status | Determined by serum ferritin | Posted | Median | Inter-Quartile Range | µg/L | Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
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| Primary | Iron Status | Determined by serum ferritin | Posted | Median | Inter-Quartile Range | µg/L | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
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| Primary | Iron Status BRINDA Adjusted | Determined by serum ferritin BRINDA adjusted | Posted | Median | Inter-Quartile Range | µg/L | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
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| Primary | Iron Status BRINDA Adjusted | Serum ferritin BRINDA adjusted | Posted | Median | Inter-Quartile Range | µg/L | Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | z score | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | z score | Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | z score | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | z score | Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
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| Primary | Immune Function | Immune responses primarily defined as protective anti-measles IgG titers (>16.5 AU/mL). | Children with reported vaccination of the measles-containing vaccine confirmed by maternal-child health card and available anti-measles immunoglobulin G titer. | Posted | Count of Participants | Participants | Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
|
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| Primary | Immune Function | Immune responses primarily defined as response to measles vaccine | Children with reported vaccination of the measles-containing vaccine confirmed by maternal-child health card and available anti-measles immunoglobulin G titer at both baseline and endpoint to calculate change in measles IgG titer over time | Posted | Median | Inter-Quartile Range | AU/mL | Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline) |
|
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|
| 0 |
| 112 |
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | CtrlPM | 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. CtrlPM: 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. | 0 | 111 | 0 | 111 | 0 | 111 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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