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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT00004495
Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
* Diagnosis of end stage renal disease requiring regular hemodialysis treatment 3 times weekly
* Baseline predialysis total homocysteine concentration in plasma greater than 16 micromoles/L
* No prior or concurrent pernicious anemia
* No blood smear examination showing unexplained macrocytosis
--Prior/Concurrent Therapy--
* Chemotherapy: No concurrent chemotherapy for cancer
* Other: No concurrent levodopa or carbidopa No concurrent penicillamine or trimethoprim-sulfonamide combination No concurrent antiviral therapy No concurrent anticonvulsants
--Patient Characteristics--
* Hematopoietic: Hematocrit at least 25%
* Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No Parkinson's disease No convulsions or epilepsy requiring treatment No lactose intolerance or allergy to milk products No history of allergic sensitization following administration of folic acid, pyridoxine (vitamin B6), or cyanocobalamin (vitamin B12) No vitamin B12 concentration below lower limit of normal (150 picamole/L) No untreated hypothyroidism or psoriasis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
89 Years
Study:
NCT00004495
Study Brief:
Protocol Section:
NCT00004495