Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT03853304
Eligibility 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:
* 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT03853304
Study Brief:
Protocol Section:
NCT03853304