Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Measure changes in median serum folate levels between baseline and study endpoint
研究概览
简要总结
Question: How effective is folic acid-fortified iodized salt in increasing serum folate concentrations among non-pregnant and non-lactating women of reproductive age? Hypothesis: Folic acid-fortified iodized salt can increase serum folate levels and serve as a policy consideration in salt fortification with both iodine and folic acid to reduce serious and fatal birth defects.
详细描述
Salt is an ideal vehicle for fortification because its universal consumption and often centrally processed with established distribution channels. Over 70% of households globally have access to iodized salt. Considering the success of salt iodization, it is logical to use the existing infrastructure to provide folic acid through this dietary mechanism.
AIM:To assess increase in blood folate concentrations among women of reproductive age after they consume folic acid-fortified iodized salt.
OBJECTIVES :
- To examine the effect of consumption of salt fortified with folic acid on serum/plasma folate concentrations among women of reproductive age.
- To estimate the raise in serum iron, B12 and folate levels after 3 months of study salt consumption.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Willing to voluntarily participate in the study
- •Can comprehend and comply with study requirements
- •Aged between 18 and 45 years.
- •No documented issues with child bearing potential
- •Resident of the area of study for duration of study.
- •Consume only study salt during study
排除标准
- •Taking multivitamins or FA during study
- •Pregnant or lactating at recruitment or during study
- •Co-morbidities such as Malabsorption disorders, severe anemia (Hgb <8.0 g/dL), uncontrolled hypertension, (SBP ≥140 mm Hg or DBP ≥90 mm Hg), HIV, active TB or malaria infection
- •History of prior SBA delivery
- •Pre-existing medical conditions (i.e., cancer or need for regular medications)
结局指标
主要结局
Measure changes in median serum folate levels between baseline and study endpoint
时间窗: 2-6 months
evaluate blood levels pre- and post-intake of study salt (fortified with folic acid)
次要结局
未报告次要终点