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| Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Centers for Disease Control and Prevention |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00613717 |
Purpose
The Healthy Infant Development Project will determine if providing micronutrient supplements to mothers during pregnancy and infants in the first 9 months fosters healthy behavior and development in babies.
| Condition | Intervention |
|---|---|
|
Iron Deficiency Anemia Iron Deficiency |
Dietary Supplement: folic acid + iron prenatally, vits A & D + iron postnatally Dietary Supplement: folic acid + iron prenatally, vitamins A & D postnatally Dietary Supplement: folic acid prenatally, vitamins A & D + iron postnatally Dietary Supplement: folic acid prenatally, vitamins A & D postnatally Dietary Supplement: multimicronutrients prenatally, vits A&D+iron postnatally Dietary Supplement: multimicronutrients prenatally, vits A&D postnatally |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study |
| Official Title: | Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts |
| Estimated Enrollment: | 2400 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
a: Experimental
pre- and early postnatal iron
|
Dietary Supplement: folic acid + iron prenatally, vits A & D + iron postnatally
Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D. |
|
b: Experimental
iron prenatal only
|
Dietary Supplement: folic acid + iron prenatally, vitamins A & D postnatally
Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D. |
|
c: Experimental
iron early postnatal only
|
Dietary Supplement: folic acid prenatally, vitamins A & D + iron postnatally
Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D. |
|
d: Active Comparator
no iron pre- or postnatal
|
Dietary Supplement: folic acid prenatally, vitamins A & D postnatally
Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D. |
|
e: Experimental
prenatal multimicronutrients and early postnatal iron
|
Dietary Supplement: multimicronutrients prenatally, vits A&D+iron postnatally
Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery; folic acid 400 mcg, Fe 30 mg, vitamin (vit) A 800 mcg, vit E 10 mg, vit D 5 mcg, vit C 70 mg, vit B1 1.4 mg, vit B2 1.4 mg, vit B6 1.9 mg, vit B12 2.6 mcg, Niacin 18 mg, Zn 15 mg, Cu 2 mg, Iodine 150 mcg, Selenium 65 mcg. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D. |
|
f: Experimental
prenatal multimicronutrients only
|
Dietary Supplement: multimicronutrients prenatally, vits A&D postnatally
Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery; folic acid 400 mcg, Fe 30 mg, vitamin (vit) A 800 mcg, vit E 10 mg, vit D 5 mcg, vit C 70 mg, vit B1 1.4 mg, vit B2 1.4 mg, vit B6 1.9 mg, vit B12 2.6 mcg, Niacin 18 mg, Zn 15 mg, Cu 2 mg, Iodine 150 mcg, Selenium 65 mcg. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D.
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Iron deficiency (ID) is the most common single nutrient disorder in the world, and pregnant women and infants are at highest risk. With long-lasting differences in prior studies, effects on the developing brain and infant behavior and development are among the most worrisome concerns. However, fundamental questions about causality, timing, duration, and severity of early ID remain unanswered. The proposed study will determine developmental/ behavioral effects of preventing ID depending on timing and duration of iron supplementation (i.e., pre- and/or early postnatally). The study will relate outcomes to severity of ID and consider reversibility of effects with iron therapy, depending on timing.
The project entails 2 randomized controlled trials (RCTs) to support causal inferences about preventing ID pre- and/or early postnatally. The project builds on a large CDC-supported study involving 15,000 pregnant women in rural China (ClinicalTrials.gov identifier: NCT00133744).
Aims 1 & 2 entail 2 preventive RCTs to support causal inferences about timing and duration. Comparing available approaches - screening & treatment, iron supplementation and its timing, or multimicronutrients- will make the results highly relevant to global practice and policy.
Aim 1: To determine effects of timing of iron deficiency prevention on infant behavior and development. The 3-group design of the CDC-supported Prenatal Nutrition Study will support causal inferences about effects of prenatal iron supplementation (with or without multimicronutrients) on newborn behavior and development. A RCT of early postnatal iron supplementation will be added to focus on iron supplementation in the 1st 9 mo, when benefits of supplemental iron for breast-fed infants are unknown. Infants are assigned randomly (double-blind) within prenatal group to receive vitamins with or without iron from 6 wk to 9 mo. Development/behavior is evaluated at 9 and 18 mo, with outcomes in sensory, motor, cognitive, language, and social/ emotional domains. Using intention to treat, the groups are a) pre- and early postnatal iron, b) iron prenatal only, c) iron early postnatal only, d) neither, e) prenatal multimicronutrients and early postnatal iron, and f) prenatal micronutrients only. Comparisons of b) v. c) relative to d) will identify differential effects of preventing iron deficiency depending on timing and will support causal inferences regarding supplementation in each period. Comparing b) v. f) will determine if outcomes are better with prenatal multimicronutrients than iron alone.
Aim 2: To determine effects of duration of iron supplementation on infant behavior/development. Comparing groups a) pre- and early postnatal iron v. b) or c) will determine if the duration of iron supplementation has different behavioral/developmental effects. Comparing a) v. e) will determine if outcomes are better with than without prenatal multimicronutrients.
Eligibility| Ages Eligible for Study: | up to 5 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Full-term healthy neonates born to study mothers from CDC's Prenatal Nutrition Study with randomly selected lot numbers.
Exclusion Criteria:
Contacts and Locations| Contact: Betsy Lozoff, MD | 7347642443 | blozoff@umich.edu |
| China | |
| National Center for Maternal and Infant Health | |
| Beijing, China, 100083 | |
| Principal Investigator: | Betsy Lozoff, MD | University of Michigan |
| Study Director: | Li Zhu, MD | National Center for Maternal and Infant Health |
More Information
| Responsible Party: | University of Michigan ( Betsy Lozoff, Professor of Pediatrics and Communicable Diseases ) |
| Study ID Numbers: | 1R01HD052069-01A2, 1R01HD052069-01A2 |
| Study First Received: | February 11, 2008 |
| Last Updated: | May 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00613717 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
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iron deficiency anemia iron deficiency infant development behavior |
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Healthy Iron Metabolism Disorders Vitamin B 6 Anemia, Iron-Deficiency Selenium Nicotinic Acids Malnutrition Retinol palmitate Nutrition Disorders Iodine Deficiency Diseases Metabolic Diseases Hematologic Diseases |
Hydroxocobalamin Anemia Ergocalciferols Thiamine Vitamin B 12 Folic Acid Vitamin D Vitamin A Pyridoxine Metabolic disorder Iron Niacin |
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Anticarcinogenic Agents Vitamin B Complex Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematinics Growth Substances Physiological Effects of Drugs |
Hematologic Agents Anemia, Hypochromic Trace Elements Protective Agents Pharmacologic Actions Vitamins Therapeutic Uses Micronutrients |
