Effectiveness Study of Folic Acid Fortified Iodized Salt to Increase Folate Concentrations in Women of Reproductive Age in Zambia, a Non-fortifying Country
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)
研究概览
简要总结
Question: How effective is fortified iodized salt with folic acid (FISFA) in increasing serum and red blood cell folate in non-lactating, non-pregnant women of reproductive age in the country of Zambia who do not have active food fortification with a folic acid program?
Participants will:
- Consume salt with folic acid instead of their regular salt for 6 months
- Have a blood draw 4 times
- Fill out surveys
详细描述
The objective of this nonrandomized controlled intervention trial is to measure the effectiveness of fortified iodized salt with folic acid (FISFA) on increasing blood folate concentrations as a preventive measure against folate-sensitive neural tube defects (NTDs) in a non-fortifying country of Zambia.
The main questions it aims to answer are:
Aim 1: Measure the effectiveness of FISFA on increasing serum and red blood cell folate concentrations in women of reproductive age in a non-fortifying country.
Aim 2: Assess the risk of neural tube defects by measuring folate insufficiency levels via serum and red blood cell concentrations in women of reproductive age in a non-fortifying country.
Aim 3: Assess taste and color acceptability of FISFA by study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Voluntary participation in the study
- •Do not intend to get pregnant
- •Not lactating or pregnant
- •Live alone or with a partner if they can be compliant and not share the study salt.
- •Aged between 18 and 45 years
排除标准
- •Pregnant or lactating
研究组 & 干预措施
FISFA arm
Dietary Supplement: fortified iodized salt with folic acid (FISFA)
干预措施: Fortified Iodized Salt with Folic Acid (FISFA) (Dietary Supplement)
结局指标
主要结局
Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint)
时间窗: 0-6 months
Evaluate folate blood levels pre and post intervention
Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint)
时间窗: 0-6 months
Evaluate folate blood levels pre and post intervention
次要结局
- Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale)(1,3,6 months)
- Measure of folate insufficiency via serum and RBC concentration(0-6 months)
研究者
Anastasia Smith
Clinical Research Manager
University of Alabama at Birmingham