Clinical trial NCT01375660: D Vitamin Intervention in VA
Official title: Vitamin D Deficiency and Treatment in Male Veterans at Risk for Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Fasting Glucose
Impaired Glucose Tolerance
Vitamin D Insufficiency
Keywords: Vitamin D
Glucose intolerance
African American men
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-06-17
Enrollment: 205
Sex: MALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Oral Glucose Insulin Sensitivity (OGIS)
timeFrame: 12 months
Secondary outcomes:
measure: Change in HbA1c From Baseline at 12 Months
timeFrame: Baseline and 12 Months
measure: Insulin Sensitivity by Matsuda Composite
timeFrame: 12 Months
measure: Insulinogenic Index-30
timeFrame: 12 Month
measure: C-Peptidogenic Index-30
timeFrame: 12 Month
measure: Incident Diabetes
timeFrame: 12 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
Study officials:
affiliation: Jesse Brown VA Medical Center, Chicago, IL
name: Elena I. Barengolts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ciubotaru I, Green SJ, Kukreja S, Barengolts E. Significant differences in fecal microbiota are associated with various stages of glucose tolerance in African American male veterans. Transl Res. 2015 Nov;166(5):401-11. doi: 10.1016/j.trsl.2015.06.015. Epub 2015 Jul 8.
citation: Eisenberg Y, Mohiuddin H, Cherukupally K, Zaidi H, Kukreja S, Barengolts E. Similarities and differences between patients included and excluded from a randomized clinical trial of vitamin D supplementation for improving glucose tolerance in prediabetes: interpreting broader applicability. Trials. 2015 Jul 15;16:306. doi: 10.1186/s13063-015-0812-0.
citation: Barengolts E, Manickam B, Eisenberg Y, Akbar A, Kukreja S, Ciubotaru I. EFFECT OF HIGH-DOSE VITAMIN D REPLETION ON GLYCEMIC CONTROL IN AFRICAN-AMERICAN MALES WITH PREDIABETES AND HYPOVITAMINOSIS D. Endocr Pract. 2015 Jun;21(6):604-12. doi: 10.4158/EP14548.OR. Epub 2015 Feb 25.