Healthy Infant Development Project
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| ClinicalTrials.gov Identifier: NCT00613717 |
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Recruitment Status :
Completed
First Posted : February 13, 2008
Last Update Posted : October 29, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Not Applicable |
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. The proposed study will determine developmental/ behavioral effects of preventing ID depending on timing (Aim 1) and duration (Aim 2) of iron supplementation (i.e., pre- and/or early postnatally). The study will relate outcomes to severity of ID (Aim 3) and consider reversibility of effects with iron therapy, depending on timing (Aim 4). We expect different neurobehavioral effects when ID occurs or is prevented/treated during different phases of brain development (proliferation and growth phase primarily prenatally and regional diversification and interconnection largely in infancy). 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 US CDC-supported study (Pregnancy Nutrition Study) involving pregnant women in rural China (ClinicalTrials.gov identifier: NCT00133744). Study groups of infants in the proposed RCTs combined are a) pre- and early postnatal iron, b) prenatal iron, c) early postnatal iron, and d) neither (n = 500/group, total 2000, at study end). Iron status and sensitive sensory, motor, cognitive, language, and social-emotional outcomes will be assessed at birth, 9 and 18 mo. Results of Aims 1 & 2 will determine the best window to prevent ID effects and whether breast-fed infants benefit from iron before 6 mo. Aim 3 (severity) will determine the level of ID at which different developmental domains are adversely affected. If ill effects of ID without anemia are documented, there could be major policy implications; screening is currently only for anemia. Detecting more or less vulnerable domains may also point to other interventions in addition to iron therapy. To identify reversibile effects, depending on age of treatment (Aim 4), outcomes at 18 mo will be compared for infants 1) never iron-deficient, 2) poor iron status at birth and assigned to postnatal iron, 3) maternal IDA (anemia) treated in the 1st or 2nd trimester, 4) infant IDA treated at 9 mo, and 5) IDA treated at 18 mo. The results will be highly relevant to global practice and policy regarding ID, which differentially affects poor and/or minority women and infants everywhere.
The project is expected to continue with a 5-year follow-up (Nov 2014- Oct 2019).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2371 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | June 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: a
pre- and early postnatal iron
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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. |
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Experimental: b
iron prenatal only
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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. |
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Experimental: c
iron early postnatal only
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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. |
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Active Comparator: d
no iron pre- or postnatal
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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. |
- Infant behavior and development [ Time Frame: 9 and 18 months ]
- Infant anemia [ Time Frame: 9 and 18 months ]
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| Ages Eligible for Study: | up to 5 Days (Child) |
| Sexes Eligible for Study: | All |
| 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:
- birth weight < 2500 g
- gestational age ≤ 37 wk
- major perinatal complications
- major congenital anomaly
- multiple birth.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613717
| China | |
| Peking University First Hospital | |
| Beijing, China, 100034 | |
| Principal Investigator: | Betsy Lozoff, MD | University of Michigan | |
| Study Director: | Li Ming, MD | Peking University First Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00613717 History of Changes |
| Other Study ID Numbers: |
1R01HD052069-01A2 ( U.S. NIH Grant/Contract ) 1R01HD052069-01A2 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 13, 2008 Key Record Dates |
| Last Update Posted: | October 29, 2014 |
| Last Verified: | March 2014 |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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iron deficiency anemia iron deficiency infant development behavior |
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases Vitamins Folic Acid Vitamin A Vitamin D Iron Vitamin B Complex |
Retinol palmitate Micronutrients Growth Substances Physiological Effects of Drugs Trace Elements Hematinics Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Bone Density Conservation Agents |