D Vitamin Intervention in VA (DIVA)

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Impaired Glucose Tolerance

Impaired Fasting Glucose

Vitamin D Insufficiency

Treatments

Drug: Placebo

Drug: 50K vitamin D2

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01375660

CLIN-001-10S

Details and patient eligibility

About

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.

Full description

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.

Enrollment

205 patients

Sex

Male

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

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