Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children

NCT ID: NCT00944606

Last Updated: 2012-03-01

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-08-31

Brief Summary

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Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain.

Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal pain in children.

Detailed Description

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Conditions

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Hypovitaminosis D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Vitamin D

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

2000-3000 IU Vitamin D daily x 6 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo candy

Intervention Type OTHER

candy gum drops

Interventions

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Vitamin D

2000-3000 IU Vitamin D daily x 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo candy

candy gum drops

Intervention Type OTHER

Other Intervention Names

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Rainbow Light

Eligibility Criteria

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Inclusion Criteria

* ages 5-14
* healthy
* vague musculoskeletal pain without diagnosis

Exclusion Criteria

* medications (steroids, seizure medications, birth control pills or shot)
* endocrinopathies
Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Szalay

Professor, Pediatric Orthopaedics & Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth A Szalay, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico General Clinical Research Center

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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HRRC 09-167

Identifier Type: -

Identifier Source: org_study_id

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