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NCT00944606 Clinical Trial

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

Hypovitaminosis D Clinical Trial

Official title:
Vitamin D vs Placebo in the Treatment of Vague Musculoskeletal Pain in Children

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00944606
Other study ID # HRRC 09-167
Secondary ID
Status Withdrawn
Phase N/A
First received July 21, 2009
Last updated February 29, 2012
Start date July 2009
Est. completion date August 2011

Study information
Verified date February 2012
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 14 Years
Eligibility Inclusion Criteria:

- ages 5-14

- healthy

- vague musculoskeletal pain without diagnosis

Exclusion Criteria:

- medications (steroids, seizure medications, birth control pills or shot)

- endocrinopathies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Vitamin D
2000-3000 IU Vitamin D daily x 6 weeks
Other:
• Placebo candy
candy gum drops

Locations
Country Name City State
United States University of New Mexico General Clinical Research Center Albuquerque New Mexico

Sponsors (1)
Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lessening of musculoskeletal pain level and frequency 6 weeks No
Secondary Improvement of serum 25 OH Vitamin D level 6 weeks No
Secondary Decline of serum parathyroid hormone levels 6 weeks No
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