D Vitamin Intervention in VA

NCT ID: NCT01375660

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-11-30

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.

Conditions

Impaired Fasting Glucose; Impaired Glucose Tolerance; Vitamin D Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Placebo: One capsule weekly

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K

Arm 2

50K vitamin D2: One capsule weekly

Group Type: EXPERIMENTAL

50K vitamin D2

Intervention Type: DRUG

Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K

Interventions

Placebo

Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K

Intervention Type: DRUG

50K vitamin D2

Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena I. Barengolts, MD

Role: PRINCIPAL_INVESTIGATOR

Jesse Brown VA Medical Center, Chicago, IL

Locations

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26209747 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26174313 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25716637 (View on PubMed)

Other Identifiers

CLIN-001-10S

Identifier Type: -

Identifier Source: org_study_id