Adherence With Iron Sprinkles Among High-Risk Infants
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ClinicalTrials.gov Identifier: NCT00136266 |
Recruitment Status :
Completed
First Posted : August 29, 2005
Last Update Posted : February 3, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia Iron Deficiency | Drug: Ferrous sulphate drops with vitamins A, D, and C Drug: Ferrous fumarate sprinkles with vitamins and minerals | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Adherence With Iron Sprinkles Among High-Risk Infants |
Study Start Date : | March 2005 |
Actual Primary Completion Date : | December 2005 |
Actual Study Completion Date : | December 2005 |

- full adherence, use of iron supplements 6-7 days/week for 3 months
- iron deficiency at 9 months of age
- anemia at 9 months of age

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Ages Eligible for Study: | 5 Months to 7 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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): NCT00136266
United States, Massachusetts | |
Whittier Street Health Center | |
Boston, Massachusetts, United States, 02108 | |
Boston Medical Center Pediatric Primary Care Clinic | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Paul L. Geltman, MD, MPH | Boston University |
ClinicalTrials.gov Identifier: | NCT00136266 |
Other Study ID Numbers: |
CDC-NCCDPHP-MM-0835-O5/05 CDC-MM-0835-O5/05 |
First Posted: | August 29, 2005 Key Record Dates |
Last Update Posted: | February 3, 2016 |
Last Verified: | September 2007 |
Adherence Supplements Iron Iron deficiency |
Anemia Vitamins Minerals |
Anemia, Iron-Deficiency Anemia Hematologic Diseases Anemia, Hypochromic Iron Metabolism Disorders Metabolic Diseases Vitamin D |
Vitamins Vitamin A Ferrous fumarate Micronutrients Physiological Effects of Drugs Trace Elements Bone Density Conservation Agents |