Trials / Completed
CompletedNCT00701246
Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil
Nutritional Anemia: Prevention and Treatment in Early Childhood
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 196 (actual)
- Sponsor
- Universidade Federal de Goias · Academic / Other
- Sex
- All
- Age
- 6 Months – 24 Months
- Healthy volunteers
- Not accepted
Summary
Iron deficiency anemia is the most common nutritional problem in the world. The objectives of this study are: * to evaluate the prevalence of anemia in children from 6 to 24 months of age and the therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin levels. * to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic Study hypothesis: * The ferrous sulfate plus folic acid can improve the response on hemoglobin levels. * The folic acid supplementation with ferrous sulfate have effect on the linear and weight growth of anemic and non-anemic.
Detailed description
Purpose The objective of this study were: * to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid. * to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic. A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goias State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50μg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50μg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ferrous sulfate | |
| DRUG | folic acid | |
| DRUG | placebo (folic acid) |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2006-03-01
- Completion
- 2006-03-01
- First posted
- 2008-06-19
- Last updated
- 2014-03-13
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT00701246. Inclusion in this directory is not an endorsement.