Randomized trial of micronutrient-fortified salt in women in Southern India
- Registration Number
- CTRI/2024/04/066208
- Lead Sponsor
- Cornell University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Women between 18 and 49 years of age
- Healthy
- Not pregnant or lactating
- Plan to reside in the catchment area of our periconceptional surveillance program for at least two years
- Severe anemia, i.e., Hemoglobin less than 8.0 g/dL
- Reported diagnosis of HIV, malaria infection, or active tuberculosis disease
- Malabsorption disorders
- Stage 2 hypertension, i.e., SBP =140 or DBP =90 mmHg
- Glycated hemoglobin, HbA1c =6.5%
- Other serious pre-existing medical conditions, active infections, or acute illnesses
- Previous pregnancy affected by a neural tube defect
- Planning to become pregnant in the next 12 months
- Daily micronutrient supplements, i.e., tablets capsules or dispersible tablets =4 times in the past week
- Intramuscular or intravenous interventions containing medications or micronutrients in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Red blood cell (RBC) folate and serum folate concentrations, nmol/L <br/ ><br>- Hemoglobin concentrations, g/dL <br/ ><br>- Vitamin B12 concentrations, pmol/LTimepoint: Endpoint, i.e., 12 months
- Secondary Outcome Measures
Name Time Method Anemia, i.e., Hemoglobin less than 12.0 g/dLTimepoint: Endpoint, i.e., 12 months;Folate deficiency and insufficiency, i.e., RBC folate less than 305 nmol/L and less than 748 nmol/LTimepoint: Endpoint, i.e., 12 months;Vitamin B12 deficiency and insufficiency i.e., total vitamin B12 less than 148.0 pmol/L and less than 221.0 pmol/LTimepoint: Endpoint, i.e., 12 months