None listed
Conditions
Interventions
Intervention1: DFS + Folic acid: Salt fortified with iron, iodine, and folic acid
Intervention2: DFS + Vitamin B12: Salt fortified with iron, iodine, and vitamin B12
Intervention3: Quadruple-Fortified
Sponsors
Cornell University
Eligibility
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Red blood cell (RBC) folate and serum folate concentrations, nmol/L - Hemoglobin concentrations, g/dL - Vitamin B12 concentrations, pmol/LTimepoint: Endpoint, i.e., 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Prakash Babu Narasimhan
Arogyavaram Medical Center
Outcome results
None listed