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临床试验/NCT00655408
NCT00655408已完成不适用

Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs

Sao Jose do Rio Preto Medical School0 个研究点目标入组 130 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
主要终点
Test (serum hemoglobin)

研究概览

简要总结

This work aims at establishing the effectiveness of weekly doses of ferrous sulfate administered by mothers compared with weekly supplements administered directly by healthcare professionals, to reducing anemia prevalence.

详细描述

Some studies have shown satisfactory results in reducing the prevalence of iron deficiency using weekly doses of ferrous sulfate, thereby avoiding these side effects. This deficiency is the most common nutritional disorder during childhood and does not only affect individuals from developing countries but also those from industrialized nations.

For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency. In this age range the prevalence of anemia is at least 20%. However, studies have shown a low rate of compliance by mothers during the recommended period, which may be caused by a lack of care or, more probably, due to the side effects caused by long-term daily ferrous sulfate supplementation, which include nausea, vomiting, diarrhea, staining of teeth and abdominal pain.

This specific study is randomized clinical trial study, achieved in a government healthcare clinic in Sao Jose do Rio Preto, Sao Paulo, Brazil. This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron, either administered in the government healthcare clinic or at the children's home.

The study showed treatment compliance in both groups. Prevalence of anemia for all children was 75% at the beginning of supplementation and 46.3% at the end of the period (p < 0.0005). Reduction rate for anemic children was 38.3%. Average increases in hemoglobin concentration levels were 0.75 g/dL and 0.65 g/dL, respectively, for home interventions and healthcare clinic administration (p < 0.00005).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Ages ranging between six and 24 months old

排除标准

  • Positive results for the Guthrie test
  • Use of ferrous sulfate supplements
  • Infections process at the time of first consultation

研究组 & 干预措施

A

Active Comparator

For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency.This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron.

Group 1 administered in the government healthcare clinic. Group 2 administered children's home.

The study showed treatment compliance in both groups.

干预措施: elemental iron (Drug)

结局指标

主要结局

Test (serum hemoglobin)

时间窗: assessed at the before of the treatment period

次要结局

  • Test (serum hemoglobin)(assessed after 12 weekly with iron supplement)

研究者

发起方
Sao Jose do Rio Preto Medical School
申办方类型
Other

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