Anemia
Conditions
Keywords
Anemia, Iron deficiency anemia, Infants, Children, Clinical trials, Ferrous sulfate, Folic acid, Daycare centers, Anaemia in children, born at term, non-twins, with parental approval for participation in the study, growth
Brief 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.
Interventions
Sponsors
Federal University of São Paulo
Ministry of Health, Brazil
Goiania Municipal Health Department
Universidade Federal de Goias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* from 6 to 24 months * born at term * non-twins * with parental approval for participation in the study * attending municipal daycare centers with mor than four children each
Exclusion criteria
* Children with special needs * low birth weight (\<2.500g) * with growth-impairing heart diseases * neurological syndromes * sickle-cell anemia * sickle-cell trait * under treatment for anemia at the time of the first interview or screening performed by the pediatrician * those no longer attending the daycare center * the clinical trial excluded children with hemoglobin \>=7 amd \<=8g/dL. * For the second objective: incomplete anthropometric surveys
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Iron status | Approximately three months |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of anemia | Approximately three months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Linear ad weight gain of anemic and non-anemic | Approximately three months | Linear and weight gain of anemic and non-anemic observed by anthropometric surveys (Z-score for weight-for-age, Z-score for height-for-age, Z-score for weight-for-height, average monthly weight, monthly length gain, and gain of Z-scores for weight-for-age, height-for-age, weight-for-height) |
Countries
Brazil
Outcome results
None listed