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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01258660
Eligibility Criteria:
Inclusion Criteria:
* Age 18-40 years.
* RBC folate \> 317 nmol/L and \< 906 nmol/L.
* At least 1 menstruation during the last 3 months before screening with the exception of women using progestin-only methods (injection, implant) or progestin-releasing intrauterine system (IUS).
* Negative pregnancy test at screening and at admission into the study.
* Healthy as confirmed by medical history and physical examination.
* Body mass index (BMI) of 18.5-30.0 kg/m2 .
* Volunteers that smoke less than 10 cigarettes per day can be included up to the age of 30 years.
* Adequate vitamin B12 status defined as plasma B12 concentrations ≥ 110 pmol/L.
Exclusion Criteria:
* Regular intake of folic acid defined as \> 100 μg folic acid/day in vitamin supplements or fortified food during the last 4 months.
* Treatment with the following medications, which has the potential of interfering with folate metabolism: cholestyramine, methotrexate, trimethoprim, sulfasalazine, salicylic acid, cotrimoxazol, antacids or antiepileptic drugs.
* Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or lactation before start of treatment)
* Vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders
* Any disease or condition that could compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.
* Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results (e.g., herpes gestationis or idiopathic icterus pregnancy; middle-ear deafness ; Sydenham's chorea, porphyria, disturbances in the bile flow.
* Liver diseases: Presence or history of severe hepatic diseases including benign or malignant tumors
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01258660
Study Brief:
Protocol Section:
NCT01258660