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