Vitamin D Supplementation and and Glycemic Indexes

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

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-02

Study Completion Date

2015-09-19

Brief Summary

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Age affect insulin sensitivity and the metabolism, and vitamin D status was shown to have a correlation with markers of insulin resistance. That's why, we aimed in our trial to study the effect of vitamin D supplementation on glycemic markers and index of insulin resistance.

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Detailed Description

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A low serum 25-hydroxyvitamin D \[(25(OH) D)\] concentration was shown to correlate with higher fasting blood glucose (FBG) and insulin levels. Since age affect insulin sensitivity and the metabolism, we aimed in this randomized controlled trial to investigate the effect of vitamin D supplementation on glucose homeostasis and index of insulin resistance in elderly subjects living in Beirut, Lebanon.

Participants (n= 115) deficient in vitamin D were randomly divided into two groups, a group receiving 30,000 IU cholecalciferol/week for a period of 6 months, and a placebo group. The index of insulin resistance HOMA (homeostasis model assessment) was the primary outcome. Glucose homeostasis and metabolic markers were also measured at start of treatment and at 6 months.

Conditions

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Deficiency, Vitamin D Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a randomized, controlled, double blind study. Participants were randomized into 2 groups; the vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) and the placebo group who also received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving. The treatment was led for a period of 6 months.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Neither the investigator nor the subjects were aware of the group allocation; the pharmacist (in charge of the placebo tablets as well as the packing and coding of the supplements) was the only person to know to which group each participant belonged.

Study Groups

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Vitamin D group

The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)

Group Type EXPERIMENTAL

cholecalciferol (Euro-Pharm International, Canada)

Intervention Type DIETARY_SUPPLEMENT

Placebo group

The placebo group received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)

Interventions

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cholecalciferol (Euro-Pharm International, Canada)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

-Deficiency in vitamin D and having no medical history of type 2 diabetes mellitus

Exclusion Criteria

patients with a history of type-2-diabetes, congestive heart failure, liver failure, renal failure, cancer, or taking oral hypoglycemic drugs or statin therapy, or patients having metabolic bone disease.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes