Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

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

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-01-31

Brief Summary

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The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.

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Detailed Description

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Twenty normal weight adolescents between ages 12-18 that are age and gender would receive vitamin D3 supplementation at a dose of 2000 IU/day. Levels of 25(OH)vitamin D would be measured at baseline and after 12 weeks.Relationship between 25 OH vitamin D levels and other demographic variables will be assessed.The primary endpoint in this study is the 25 OH Vitamin D level at 12 weeks.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D3

Patients would receive 2000 IU of vitamin D3 daily for 12 weeks

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

2000 IU orally once daily for 12 weeks

Interventions

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Vitamin D3

2000 IU orally once daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Subjects between ages 12 and 18 years with BMI between the 5th and the 85th percentile for age and gender.

Exclusion Criteria

* Subjects with 25 (OH)- D levels \>80 ng/mL
* Serum calcium \>10.8 mg/dL
* Serum phosphorus \> 5.5 mg/dl
* Pregnancy or nursing
* Current cancer
* Patients on multivitamin supplementation
* Dietary calcium intake exceeding 1500 mg/day
* Hepatic or renal disorders
* Type 1 or Type 2 diabetes mellitus
* Those receiving insulin, metformin, or oral hypoglycemic medications
* Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes