Does Vitamin D Improve Glycemic Control in Type II DM?

NCT ID: NCT01170442

Last Updated: 2015-04-01

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.

Detailed Description

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Conditions

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Diabetes Mellitus Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vitamin D3 2000 IU

Group Type EXPERIMENTAL

vitamin D3 2000 IU

Intervention Type DRUG

vitamin D3 2000 IU orally, daily for 6 months

vitamin D3 5000 IU

Group Type EXPERIMENTAL

vitamin D3 5000 IU

Intervention Type DRUG

vitamin D3 5000 IU orally, daily for 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo orally, daily for six months

Interventions

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vitamin D3 2000 IU

vitamin D3 2000 IU orally, daily for 6 months

Intervention Type DRUG

vitamin D3 5000 IU

vitamin D3 5000 IU orally, daily for 6 months

Intervention Type DRUG

Placebo

placebo orally, daily for six months

Intervention Type DRUG

Other Intervention Names

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cholecalciferol cholecalciferol

Eligibility Criteria

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Inclusion Criteria

* Type II diabetics living in Riyadh area who consume no more than one serving of milk/day
* Do not take vitamin supplement
* Habitually have less than 10 hour of sun exposure per week
* Don't suffer from granulomatous conditions, liver disease, or kidney disease
* Don't take anticonvulsants, barbiturates, or steroids.
* Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier)
* Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Maher Hammami

Chairman, Department of Clinical Studies & Empirical Ethics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad M Hammami, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

King Faisal Specialist Hospital & Research Center

Locations

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King Faisal Specialist Hospital & Research Center

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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RAC 2101039

Identifier Type: -

Identifier Source: org_study_id

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