N/A
Completed N=205
D Vitamin Intervention in VA
impaired fasting glucose · impaired glucose tolerance · Vitamin D Insufficiency
Source: ClinicalTrials.gov NCT01375660 ↗
Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Oral Glucose Insulin Sensitivity (OGIS) — -16.0; 7.8 ml/min/m^2 of body surface area — p=0.026
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oral Glucose Insulin Sensitivity (OGIS) |
-16.0; 7.8 | 0.026 sig |
| SECONDARY Change in HbA1c From Baseline at 12 Months |
0.01; -0.01 | 0.6 |
| SECONDARY Insulin Sensitivity by Matsuda Composite |
0.13; 0.44 | 0.389 |
| SECONDARY Insulinogenic Index-30 |
-0.03; 0.26 | 0.34 |
| SECONDARY C-Peptidogenic Index-30 |
-0.64; 5.32 | 0.22 |
| SECONDARY Incident Diabetes |
9; 9 | 0.869 |
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
Data sourced from ClinicalTrials.gov (NCT01375660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.