Effect of Multiple Micronutrient Supplementation Versus Iron and Folic Acid Supplementation on Maternal Nutritional Biomarkers and Birth Outcomes Among Pregnant Women in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Maternal Body Weight
研究概览
简要总结
Micronutrient deficiencies during pregnancy may affect the mother's nutritional status and the baby's growth. This study compared two types of daily supplements for pregnant women: a multiple micronutrient supplement and an iron and folic acid supplement.
Pregnant women in Indonesia who were at 12 weeks of gestation or earlier were randomly assigned to receive one of the two supplements for eight weeks. The study measured maternal body weight, mid-upper arm circumference, hemoglobin concentration, and serum zinc concentration before and after supplementation. Infant birth weight and the occurrence of low birth weight were assessed after delivery.
The purpose of the study was to determine whether multiple micronutrient supplementation produced greater improvements in maternal nutritional indicators and birth outcomes than iron and folic acid supplementation.
详细描述
This study was designed as a randomized, double-blind, parallel-group trial comparing daily multiple micronutrient supplementation with daily iron and folic acid supplementation among pregnant women in Indonesia. Participants received the assigned supplement for eight weeks. Maternal anthropometric and biochemical indicators were assessed before and after the intervention, and birth outcomes were assessed after delivery.
This study was registered retrospectively because prospective registration was inadvertently omitted during study initiation. Information entered in this record was derived from the original study protocol and available study documentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at 12 weeks of gestation or earlier Aged 18 to 40 years No diagnosed chronic disease Willing to complete all study procedures Provided written informed consent
排除标准
- •Severe pregnancy complications Known allergy to any supplement ingredient Inability to communicate adequately with the research team Planned relocation from the study area within the following six months
结局指标
主要结局
Change in Maternal Body Weight
时间窗: Baseline and 8 weeks
Change in maternal body weight calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in kilograms.
Change in Maternal Mid-Upper Arm Circumference
时间窗: Baseline and 8 weeks
Change in maternal mid-upper arm circumference calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in centimeters.
Change in Maternal Hemoglobin Concentration
时间窗: Baseline and 8 weeks
Change in maternal hemoglobin concentration calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in g/dL. Time Frame:
次要结局
未报告次要终点
研究者
Dr. Rosdiana Syakur
Lecturer and Principal Investigator
Indonesia Timur University