D Vitamin Intervention in VA
D Vitamin Intervention in VA
This study will supplement African American male (AAM) veterans at risk for diabetes and
 newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps
 to improve early markers of diabetes. The study will be done at Veteran Administration
 Medical Center in Chicago.
The goal of this randomized clinical trial (RCT) is to determine vitamin D efficacy and
 safety for improving early markers of T2DM in African American male (AAM) veterans at risk
 for T2DM (n=205, duration 12 months).

 The primary outcome will be change in oral glucose insulin sensitivity (OGIS). The secondary
 outcomes will include various parameters of glucose metabolism and other biomarkers.

 Analysis based on primary and secondary goal as well as predetermined levels of A1C, OGTT and
 25OHD at the end of the study.
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