Nutritional Anemia: Prevention and Treatment in Early Childhood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Iron status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
III
Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid
干预措施: folic acid (Drug)
I
I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg)
干预措施: ferrous sulfate (Drug)
I
I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg)
干预措施: folic acid (Drug)
II
II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo.
干预措施: ferrous sulfate (Drug)
II
II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo.
干预措施: placebo (folic acid) (Drug)
III
Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid
干预措施: ferrous sulfate (Drug)
IV
1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.
干预措施: ferrous sulfate (Drug)
IV
1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.
干预措施: placebo (folic acid) (Drug)
结局指标
主要结局
Iron status
时间窗: Approximately three months
次要结局
- Prevalence of anemia(Approximately three months)
研究者
Maria Claret Costa Monteiro Hadler
PhD.
Universidade Federal de Goias