- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00613717
Healthy Infant Development Project
Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts
Study Overview
Status
Conditions
Intervention / Treatment
- 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
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100034
- Peking University First Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: a
pre- and early postnatal iron
|
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. |
Experimental: b
iron prenatal only
|
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. |
Experimental: c
iron early postnatal only
|
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. |
Active Comparator: d
no iron pre- or postnatal
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infant behavior and development
Time Frame: 9 and 18 months
|
9 and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infant anemia
Time Frame: 9 and 18 months
|
9 and 18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Betsy Lozoff, MD, University of Michigan
- Study Director: Li Ming, MD, Peking University First Hospital
Publications and helpful links
General Publications
- Clark KM, Li M, Zhu B, Liang F, Shao J, Zhang Y, Ji C, Zhao Z, Kaciroti N, Lozoff B. Breastfeeding, Mixed, or Formula Feeding at 9 Months of Age and the Prevalence of Iron Deficiency and Iron Deficiency Anemia in Two Cohorts of Infants in China. J Pediatr. 2017 Feb;181:56-61. doi: 10.1016/j.jpeds.2016.10.041. Epub 2016 Nov 8.
- Lozoff B, Jiang Y, Li X, Zhou M, Richards B, Xu G, Clark KM, Liang F, Kaciroti N, Zhao G, Santos DC, Zhang Z, Tardif T, Li M. Low-Dose Iron Supplementation in Infancy Modestly Increases Infant Iron Status at 9 Mo without Decreasing Growth or Increasing Illness in a Randomized Clinical Trial in Rural China. J Nutr. 2016 Mar;146(3):612-21. doi: 10.3945/jn.115.223917. Epub 2016 Jan 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Hematologic Diseases
- Anemia, Hypochromic
- Anemia
- Iron Metabolism Disorders
- Anemia, Iron-Deficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Protective Agents
- Trace Elements
- Micronutrients
- Bone Density Conservation Agents
- Antioxidants
- Hematinics
- Anticarcinogenic Agents
- Vitamin D
- Vitamins
- Folic Acid
- Vitamin B Complex
- Iron
- Vitamin A
- Retinol palmitate
Other Study ID Numbers
- 1R01HD052069-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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