Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes

NCT ID: NCT01153243

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-06-30

Brief Summary

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Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.

Detailed Description

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Other questions in our study: In diabetic African American patients,

1. Prevalence of vitamin D deficiency?
2. Correlation/relationship between vitamin D levels, Calcium level, parathyroid hormone (PTH) and Inflammatory markers

Setting: All visits will take place at the Fantus Diabetes Clinic.

Conditions

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Vitamin D Deficiency Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ergocalciferol

The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)

Group Type ACTIVE_COMPARATOR

Ergocalciferol

Intervention Type DRUG

Active Comparator: Ergocalciferol

The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)

Placebo pill

The investigators will give intervention group 12 weeks of placebo pill (in pill every week)

Group Type PLACEBO_COMPARATOR

Placebo pill

Intervention Type DRUG

The investigators will give control group 12 weeks of 1 placebo pill every week.

Interventions

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Ergocalciferol

Active Comparator: Ergocalciferol

The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)

Intervention Type DRUG

Placebo pill

The investigators will give control group 12 weeks of 1 placebo pill every week.

Intervention Type DRUG

Other Intervention Names

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Drisdol Vitamin D

Eligibility Criteria

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Inclusion Criteria

* African Americans
* DM type 2

Exclusion Criteria

* symptomatic vitamin D deficiency
* hypocalcemia
* hypercalcemia
* malabsorption
* liver disease
* patients with creatinine \> 1.5. (CKD \>/= 3)
* pregnancy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University

OTHER

Sponsor Role collaborator

Cook County Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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John H Stroger Hospital of Cook County

Principal Investigators

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Leon Fogelfeld, MD

Role: STUDY_DIRECTOR

Cook County Health

Other Identifiers

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#07-061

Identifier Type: -

Identifier Source: org_study_id

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