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Adherence With Iron Sprinkles Among High-Risk Infants
This study has been completed.
Sponsor:
Centers for Disease Control and Prevention
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00136266
First received: August 25, 2005
Last updated: February 2, 2016
Last verified: September 2007
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Purpose
Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.
| Condition | Intervention | Phase |
|---|---|---|
| Anemia Iron Deficiency | Drug: Ferrous sulphate drops with vitamins A, D, and C Drug: Ferrous fumarate sprinkles with vitamins and minerals | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Adherence With Iron Sprinkles Among High-Risk Infants |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- full adherence, use of iron supplements 6-7 days/week for 3 months
Secondary Outcome Measures:
- iron deficiency at 9 months of age
- anemia at 9 months of age
| Enrollment: | 128 |
| Study Start Date: | March 2005 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high.
Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.
Eligibility| Ages Eligible for Study: | 5 Months to 7 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy infants
- Age 5-7 months
- Presenting for 6 months well-child care
- Caregiver speaks English or Spanish
Exclusion Criteria:
- Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)
- Inability to speak English or Spanish
- Use of vitamin or iron supplements in the previous three months
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00136266
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136266
Locations
| United States, Massachusetts | |
| Whittier Street Health Center | |
| Boston, Massachusetts, United States, 02108 | |
| Boston Medical Center Pediatric Primary Care Clinic | |
| Boston, Massachusetts, United States, 02118 | |
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
| Principal Investigator: | Paul L. Geltman, MD, MPH | Boston University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00136266 History of Changes |
| Other Study ID Numbers: |
CDC-NCCDPHP-MM-0835-O5/05 CDC-MM-0835-O5/05 |
| Study First Received: | August 25, 2005 |
| Last Updated: | February 2, 2016 |
Keywords provided by Centers for Disease Control and Prevention:
|
Adherence Supplements Iron Iron deficiency |
Anemia Vitamins Minerals |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases Vitamins Vitamin A |
Vitamin D Iron Ferrous fumarate Micronutrients Growth Substances Physiological Effects of Drugs Trace Elements Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 22, 2017