NCT01375660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 5, 2015

Completed
Last Updated

March 6, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

June 15, 2011

Results QC Date

November 25, 2014

Last Update Submit

February 17, 2015

Conditions

Impaired Fasting GlucoseImpaired Glucose ToleranceVitamin D Insufficiency

Keywords

Vitamin DGlucose intoleranceAfrican American men

Outcome Measures

Primary Outcomes (1)

  • Oral Glucose Insulin Sensitivity (OGIS)

    Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline.

    12 months

Secondary Outcomes (5)

  • Change in HbA1c From Baseline at 12 Months

    Baseline and 12 Months

  • Insulin Sensitivity by Matsuda Composite

    12 Months

  • Insulinogenic Index-30

    12 Month

  • C-Peptidogenic Index-30

    12 Month

  • Incident Diabetes

    12 Months

Study Arms (2)

Arm 1

PLACEBO COMPARATOR

Placebo: One capsule weekly

Drug: Placebo

Arm 2

EXPERIMENTAL

50K vitamin D2: One capsule weekly

Drug: 50K vitamin D2

Interventions

PlaceboDRUG

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 1
50K vitamin D2DRUG

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

Eligibility Criteria

Age35 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • 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.

    PMID: 26209747DERIVED

  • 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.

    PMID: 26174313DERIVED

  • 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.

    PMID: 25716637DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Barengolts, Attending Endocrinologist, Chief, Section of Endocrinology
Organization
Jesse Brown VA Medical Center
Elena.Barengolts@va.gov
312-569-7651

Study Officials

  • Elena I. Barengolts, MD

    Jesse Brown VA Medical Center, Chicago, IL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 17, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2013

Study Completion

November 1, 2014

Last Updated

March 6, 2015

Results First Posted

February 5, 2015

Record last verified: 2015-02

Locations

US(1)