Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation (BFe01B1)
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Purpose
Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.
| Condition | Intervention |
|---|---|
|
Iron Deficiency |
Dietary Supplement: Fer-In-Sol (ferrous sulfate) Dietary Supplement: Iron fortified cereal |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation |
- Iron status [ Time Frame: 3 times during the intervention ] [ Designated as safety issue: Yes ]
- Growth [ Time Frame: At the end of intervention ] [ Designated as safety issue: Yes ]
- Tolerance (gastrointestinal) [ Time Frame: During intervention ] [ Designated as safety issue: No ]
| Enrollment: | 171 |
| Study Start Date: | June 2001 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Medicinal Iron
|
Dietary Supplement: Fer-In-Sol (ferrous sulfate)
7.5 mg/day in the form of 0.3 ml once each day
|
|
Experimental: B
Iron fortified wet pack cereal
|
Dietary Supplement: Iron fortified cereal
1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.
|
|
No Intervention: C
Control
|
Eligibility| Ages Eligible for Study: | 1 Month to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Predominantly breastfed (at 4 months) term infants
Exclusion Criteria:
- Not predominantly breastfed at 4 months
- Premature infants
Contacts and Locations More Information
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ekhard E. Ziegler, M.D., University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00760890 History of Changes |
| Other Study ID Numbers: | R01 HD 40315 |
| Study First Received: | September 25, 2008 |
| Last Updated: | September 25, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Iron, breastfed infant |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases |
Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013