Status:
ACTIVE_NOT_RECRUITING
Quadruple Fortified Salt Trial in India
Lead Sponsor:
Cornell University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Arogyavaram Medical Centre
Conditions:
Anemia
Folate Deficiency
Eligibility:
FEMALE
18-49 years
Phase:
NA
Brief Summary
Women of reproductive age are at an increased risk of anemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of neural tube defects and othe...
Detailed Description
Women of reproductive age are at increased risk for anemia and micronutrient deficiencies, due in part to social structures and increased nutritional requirements across the conceptional period. Anemi...
Eligibility Criteria
Inclusion
- 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
- Severe anemia (Hemoglobin \<8.0 g/dL)
- Reported diagnosis of HIV, malaria infection, or active tuberculosis disease
- Malabsorption disorders (i.e., medical conditions that may affect vitamin B12 absorption or metabolism)
- Stage 2 hypertension (SBP≥140 mm Hg or DBP≥90 mm Hg)
- Glycated hemoglobin (HbA1c) ≥6.5%
- Other serious pre-existing medical conditions (e.g., defined as the need for regular medication use), active infections, or acute illnesses
- Previous pregnancy affected by a neural tube defect (i.e., who have had a fetus diagnosed as affected by a neural tube defect or have given birth to a baby with a neural tube defect) (will be referred to OB/GYN for standard of care, including folic acid supplementation, and excluded)
- Planning to become pregnant (or planning to have a child) in the next 12 months (will be referred to OB/GYN for standard of care, including folic acid supplementation, and be excluded)
- Daily micronutrient supplements (i.e., tablets, capsules, dispersible tablets; ≥4 times in the past week)
- Intramuscular or intravenous interventions containing medications or micronutrients (e.g., iron, vitamin B12, folic acid) in the past 3 months
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03853304
Start Date
October 1 2023
End Date
December 1 2024
Last Update
April 1 2024
Active Locations (1)
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1
Arogyavaram Medical Centre
Madanapalle, Andhra Pradesh, India