Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus

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

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.

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Detailed Description

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Vitamin D is typically understood to support musculoskeletal health when administered concomitantly with calcium. A number of recent studies suggest, however, that this important nutrient may play a significant role in many pathophysiological processes, including diabetes mellitus. With the prevalence of diabetes mellitus ever increasing, novel mechanisms for controlling blood glucose and hemoglobin A1c are being sought to help prevent the costly and debilitating complications of this chronic disease.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vitamin D 2000 international units daily

Group Type EXPERIMENTAL

Vitamin D3 2000 international units daily

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 2000 international unit tablets once daily for 3 months

Vitamin C 500mg daily

Group Type ACTIVE_COMPARATOR

Vitamin C 500mg daily

Intervention Type DIETARY_SUPPLEMENT

Vitamin C 500mg tablets once daily for 3 months

Interventions

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Vitamin D3 2000 international units daily

Vitamin D3 2000 international unit tablets once daily for 3 months

Intervention Type DIETARY_SUPPLEMENT

Vitamin C 500mg daily

Vitamin C 500mg tablets once daily for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus
* Hemoglobin A1c \>7% measured in the 3 months prior to randomization
* Age 21 to 75 years

Exclusion Criteria

* Renal insufficiency (defined as CrCl \<30mL/min)
* Gestational diabetes
* Malabsorption syndrome
* Patients taking vitamin D supplements at doses \>400 international units daily

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No