NCT00876928

Brief Summary

Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

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

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 14, 2013

Completed
Last Updated

June 14, 2013

Status Verified

April 1, 2013

Enrollment Period

2.8 years

First QC Date

April 6, 2009

Results QC Date

July 3, 2012

Last Update Submit

April 17, 2013

Conditions

Pre-diabetes

Keywords

pre-diabetesminoritiesoral glucose tolerance testdisposition indexinsulin secretioninsulin sensitivitydiabetes

Outcome Measures

Primary Outcomes (1)

  • Percent of Subjects Who Develop Diabetes

    Diabetes defined by a FPG\>=126 mg/dl or a 2-hr glucose concentration on an OGTT of \>=200 mg/dl

    one year

Secondary Outcomes (1)

  • Disposition Index

    Baseline, 3, 6, 9, 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects with low vitamin D levels and pre-diabetes

Drug: placebo

vitamin D

EXPERIMENTAL

Subjects with low vitamin D levels and pre-diabetes

Drug: vitamin D

Interventions

vitamin DDRUG

liquid vitamin D3 dissolved in medium chain triglyceride once a week

vitamin D
placeboDRUG

medium chain triglyceride given once per week

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 40.
  • Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
  • Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
  • Serum 25-OHD less than 30 ng/ml
  • Able and willing to provide informed consent

You may not qualify if:

  • FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
  • Major psychiatric disorder on medication (excluding successfully treated depression)
  • Diagnosed diabetes mellitus
  • HIV/AIDS
  • Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
  • History of carcinoma, except skin basal cell or squamous cell skin carcinomas
  • Heart failure, unstable angina or history of a myocardial infarction
  • Alcohol or substance abuse
  • Current treatment with glucocorticoids
  • Current treatment with diabetes medications, including metformin
  • Cushing's syndrome
  • Primary hyperparathyroidism
  • Nephrolithiasis
  • Pregnancy or breast-feeding
  • Regular visits to a tanning salon (unlikely in this minority population)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Drew University

Los Angeles, California, 90059, United States

Location

Related Publications (2)

  • Sinha-Hikim I, Duran P, Shen R, Lee M, Friedman TC, Davidson MB. Effect of long term vitamin D supplementation on biomarkers of inflammation in Latino and African-American subjects with pre-diabetes and hypovitaminosis D. Horm Metab Res. 2015 Apr;47(4):280-3. doi: 10.1055/s-0034-1383652. Epub 2014 Jul 10.

    PMID: 25011019DERIVED

  • Davidson MB, Duran P, Lee ML, Friedman TC. High-dose vitamin D supplementation in people with prediabetes and hypovitaminosis D. Diabetes Care. 2013 Feb;36(2):260-6. doi: 10.2337/dc12-1204. Epub 2012 Oct 1.

    PMID: 23033239DERIVED

MeSH Terms

Conditions

Glucose IntoleranceInsulin ResistanceDiabetes Mellitus

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Mayer B. Davidson, MD
Organization
Charles R. Drew University
mayerdavidson@cdrewu.edu
323 357-3439

Study Officials

  • Mayer B. Davidson, MD

    Charles Drew University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

June 14, 2013

Results First Posted

June 14, 2013

Record last verified: 2013-04

Locations

US(1)