NCT01655810

Brief Summary

African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

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

First Submitted

Initial submission to the registry

July 19, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

August 13, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

5.5 years

First QC Date

July 19, 2012

Last Update Submit

June 3, 2020

Conditions

Vitamin D DeficiencyType 2 Diabetes MellitusCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in carotid intima-medial thickness

    0, 6, and 12 months

Secondary Outcomes (3)

  • Change from baseline in systemic inflammatory markers

    0, 6, and 12 months

  • Serum calcium

    0, 1, 3, 6, 9, and 12 months

  • Urinary Calcium

    0, 1, 3, 6, 9, and 12 months

Study Arms (2)

Vitamin D 4000 IU

ACTIVE COMPARATOR

PO daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium carbonate

Vitamin D 600 IU

ACTIVE COMPARATOR

PO daily

Dietary Supplement: Vitamin D3Dietary Supplement: Calcium carbonate

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Multivitamin containing cholecalciferol 4000 units orally daily

Also known as: Cholecalciferol
Vitamin D 4000 IU
Calcium carbonateDIETARY_SUPPLEMENT

500 mg orally twice daily

Vitamin D 4000 IUVitamin D 600 IU

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African Americans of both genders
  • Age 50-70 years
  • Type 2 diabetes (A1C \< 9.0%), on stable therapy with oral medications, insulin, or a combination
  • (OH)D level \< 20 ng/ml
  • BP \< 140/90 mmHg; LDL \< 140 mg/dl

You may not qualify if:

  • Pregnancy
  • Cardiovascular disease
  • Stage 3 or worse chronic kidney disease
  • High urine or serum calcium or history of recurrent kidney stones
  • Unstable medical conditions or major systemic diseases such as malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Vitamin D DeficiencyDiabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

CholecalciferolCalcium Carbonate

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Carlos Bernal-Mizrachi, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2012

First Posted

August 2, 2012

Study Start

August 13, 2012

Primary Completion

February 9, 2018

Study Completion

February 9, 2018

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations

US(1)