The overarching objective of this two-phase project is to assess the effects of fortifying iodized salt with folic acid on improving women's folate status. Folate insufficiency is the primary risk factor for neural tube defects (NTDs), which are highly prevalent in Ethiopia. The purposes of Phase 2 of the project, described herein, are to complete a community-based, randomized, dose-response intervention trial of edible salt fortified with just iodine or iodine and one of two levels of folic acid among non-pregnant women of reproductive age (WRA), We will assess the effects of the intervention on women's discretionary salt intakes, markers of folate and iodine status, and incidence of any adverse events.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Red blood cell folate
Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)
Serum folate
Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)
Serum homocysteine
Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)
Serum thyroglobulin
Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)
24-hour urinary iodine excretion
Timeframe: Before and during the intervention
Serious adverse events
Timeframe: Throughout the course of the intervention, total of 26 weeks