Micronutrient-fortified Iodized Salt and Serum Concentrations of Folate, B12 and Iron 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
- 200
- 试验地点
- 2
- 主要终点
- Measure changes in median serum folate, B12 and iron levels between baseline and study endpoint
研究概览
简要总结
Question: How effective is fortified iodized salt in increasing serum concentrations of folate, B12 and iron among non-pregnant and non-lactating women of reproductive age?
Hypothesis: Micronutrient fortified iodized salt can increase serum levels (of folate, B12 and iron) and serve as a policy consideration in salt fortification with both iodine and other micronutrients 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 and other micronutrients (such as B12 and iron) through this dietary mechanism.
AIM:To assess increase in blood concentrations of folate, B12 and iron among women of reproductive age who consume micronutrient-fortified iodized salt for 3 months.
OBJECTIVES :
- To examine the effect of consumption of iodized salt fortified with folic acid, B12 and iron on serum/plasma concentrations among women of reproductive age.
- To assess acceptance of study salt for daily use during 3 months of 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 micronutrient supplements 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, B12 and iron 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, B12 and iron)
次要结局
未报告次要终点