NCT01490333

Brief Summary

Cardiovascular disease (CVD) and diabetes occur commonly among Native Americans (NA), and are leading causes of death among northern US NAs. Moreover, low vitamin D status occurs commonly in this same population. An increasing amount of evidence indicates a correlation between low vitamin D status and CVD and diabetes by contributing to a heightened pro-inflammatory environment within the endothelial lining of blood vessels leading to atherosclerotic disease, and an impaired sensitivity to insulin leading to diabetes. Our fundamental hypothesis is that low vitamin D status is a risk factor for CVD by causing a proinflammatory milieu, thereby leading to endothelial dysfunction. Additionally, the investigators hypothesize that vitamin D supplementation will reduce inflammation, thereby restoring endothelial function and ultimately reducing CVD risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

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

July 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.5 years

First QC Date

November 29, 2011

Last Update Submit

November 19, 2014

Conditions

Vitamin D DeficiencyCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • Change in markers of endothelial function

    This will be determined by evaluating CRP and lipid panel

    Baseline visit, 3 month visit and 6 month visit.

  • Change in arterial stiffness with vitamin D3 supplementation

    Change in arterial stiffness will be evaluated with radial tonometry.

    one year

Secondary Outcomes (1)

  • Plasma concentration of pro-inflammatory cytokines

    Baseline visit, 3 month visit, and 6 month visit.

Study Arms (2)

2500 IU Vitamin D3

EXPERIMENTAL
Dietary Supplement: Vitamin D3

400 IU Vitamin D3

ACTIVE COMPARATOR
Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

The vitamin D3 will be taken daily.

2500 IU Vitamin D3400 IU Vitamin D3

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory, community dwelling AI woman
  • Postmenopausal up to age 75 years; for women below age 55, postmenopausal status must be confirmed by documentation of serum FSH\>30 IU/L and estradiol \< 20 pg/ml unless a bilateral oophorectomy is documented.

You may not qualify if:

  • Serum 25(OH)D \< 10 or \> 60 ng/ml.
  • Known CVD (history of MI, coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, peripheral arterial disease with claudication).
  • Uncontrolled thyroid disease (thyroid stimulating hormone level outside of normal range).
  • Change in dose of lipid lowering medications within the preceding six weeks.
  • Mastectomy of the right breast
  • Non-English speaking, illiterate, impaired decision making.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stockbridge-Munsee Nation

Bowler, Wisconsin, 54416, United States

Location

Bad River Nation

Lac du Flambeau, Wisconsin, 54538, United States

Location

University of Wisconsin Osteoporosis Clinical Research Program

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • Gepner AD, Haller IV, Krueger DC, Korcarz CE, Binkley N, Stein JH. A randomized controlled trial of the effects of vitamin D supplementation on arterial stiffness and aortic blood pressure in Native American women. Atherosclerosis. 2015 Jun;240(2):526-8. doi: 10.1016/j.atherosclerosis.2015.04.795. Epub 2015 Apr 25.

    PMID: 25955191DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyCardiovascular Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Neil Binkley, M.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 12, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

US(3)