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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT01375660
Eligibility Criteria:
Inclusion Criteria:
Veterans at Jesse Brown VA Medical Center (JBVAMC) only
* Male
* African American race
* Age 35-85 years
* BMI 28-39.9 kg/m2
* Stable weight (+/- 10%) for at least 3 months prior to study entry
* FPG 95 - 125 mg/dl
* A1C 5.7 - 6.4%
* Circulating 25OHD 5.0 - 29.9 ng/ml
* Subjects who take ergocalciferol are allowed in the study after a washout period 1 3 month.
* Subjects who take vitamin D supplements other than ergocalciferol are allowed in the study as long as total dose is no more than 600 IU/day (including MVI and calcium plus D supplements).
* Non-diabetic subjects who are diagnosed with T2DM during screening (A1C 6.5-7%) or after randomization are allowed to continue if they follow lifestyle intervention and do not need to take anti-diabetic medications.
Exclusion Criteria:
* Subjects with T2DM
* Weight gain or loss of more than 10% within 3 months prior to the study entry
* History of kidney stones, hyperparathyroidism, sarcoidosis or hypercalcemia
* A1C \>7%.
* Very low 25OHD levels (\<5 ng/ml) and/or the presence of a physical consequence of very low vitamin D levels (hypocalcemia, hypophosphatemia, proximal muscle weakness)
* Chronic kidney disease (CKD) stage 4 and 5
* Problems that in the judgment of PI may be associated with the risk to the subject or non-compliance
* Subjects who take vitamin D supplements and not willing to go through washout period for ergocalciferol or to take no more than 600 IU/day of total vitamin D supplements
* History, clinical manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject
* Non-diabetic subjects who are diagnosed with T2DM after randomization and need to take anti-diabetic medications are brought for the final visit
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
85 Years
Study:
NCT01375660
Study Brief:
Protocol Section:
NCT01375660