Overview

D Vitamin Intervention in VA

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
US Department of Veterans Affairs
VA Office of Research and Development
Treatments:
Ergocalciferols
Vitamin D
Vitamin K
Vitamins
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