NCT00736632

Brief Summary

In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

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, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

12.7 years

First QC Date

August 15, 2008

Results QC Date

January 13, 2020

Last Update Submit

January 28, 2020

Conditions

Vitamin D DeficiencyInsulin ResistanceType 2 Diabetes MellitusCardiovascular DiseaseHypertension

Keywords

Vitamin DInsulin ResistanceType 2 Diabetes MellitusCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)

    24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.

    0, 2, and 4 months

Secondary Outcomes (8)

  • Brachial Artery Reactivity Testing

    0, 2, and 4 months

  • Macrophage Cholesterol Metabolism

    0 and 4 months

  • Serum Calcium

    0, 2, and 4 Month

  • HbA1C

    0, 2, and 4 month

  • Vitamin D

    0, 2, and 4 Month

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.

Drug: Placebo

Vitamin D

ACTIVE COMPARATOR

Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.

Drug: Vitamin D3

Interventions

Vitamin D3DRUG

Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily

Also known as: Vitamin D
Vitamin D
PlaceboDRUG

Placebo pill orally daily Calcium carbonate 500 mg twice daily

Placebo

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • (OH) vitamin D levels \< 25 ng/ml
  • Age 25 to 80 years
  • Not on insulin for diabetes treatment
  • HbA1c 5.5% -9.5%
  • Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications

You may not qualify if:

  • Pregnancy
  • Patients with systolic \>160 or diastolic \>100 mmHg
  • High urine calcium or history of recurrent kidney stones
  • Cardiovascular disease
  • Stage 3 or worse chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Universiy

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Vitamin D DeficiencyInsulin ResistanceDiabetes Mellitus, Type 2Cardiovascular DiseasesHypertension

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesDiabetes MellitusEndocrine System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Carlos Bernal-Mizrachi
Organization
Washington University in St. Louis
cbernal@wustl.edu
314-362-0947

Study Officials

  • Carlos Bernal-MIzrachi, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

August 15, 2008

First Posted

August 18, 2008

Study Start

May 1, 2006

Primary Completion

January 13, 2019

Study Completion

January 13, 2019

Last Updated

February 10, 2020

Results First Posted

February 10, 2020

Record last verified: 2020-01

Locations

US(1)