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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT01841658
Eligibility Criteria:
Inclusion Criteria:
* Screening Phase:
* Female 18-40 yr
* Body Mass index 18.5 to 24.9 or \> 30 kg/m2
* Intervention Study:
* Serum folate \< 30 nmol/L
* MTHFR677CC or MTHFR677CT genotype
Exclusion Criteria:
* Currently pregnant, pregnancy within past 12 months
* Greater than 2 previous pregnancies
* Use of prescription drugs other than oral contraceptives
* Chronic disease (diabetes, hypertension,epilepsy,cancer, kidney disease, CVD)
* Acute illness (pneumonia, urinary tract infection, mononucleosis)
* Use of antibiotics in past 30 days
* Current smoker
* Use of dietary supplements including multivitamins in past 30 days
* Habitual consumption of fortified ready-to-eat cereals
* Significant weight change in past 12 months
* Typical alcohol consumption of 2 or more drinks per day
* INTERVENTION: all above plus serum folate \> 30 nmol/L; MTHFR677TT genotype
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01841658
Study Brief:
Protocol Section:
NCT01841658