Back to resultsVitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children
Primary Purpose
Hypovitaminosis D
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Placebo candy
Sponsored by
About this trial
This is an interventional treatment trial for Hypovitaminosis D
Eligibility Criteria
Inclusion Criteria:
- ages 5-14
- healthy
- vague musculoskeletal pain without diagnosis
Exclusion Criteria:
- medications (steroids, seizure medications, birth control pills or shot)
- endocrinopathies
Sites / Locations
- University of New Mexico General Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Lessening of musculoskeletal pain level and frequency
Secondary Outcome Measures
Improvement of serum 25 OH Vitamin D level
Decline of serum parathyroid hormone levels
Full Information
NCT ID
NCT00944606
First Posted
July 21, 2009
Last Updated
February 29, 2012
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT00944606
Brief Title
Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children
Official Title
Vitamin D vs Placebo in the Treatment of Vague Musculoskeletal Pain in Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Why Stopped
inability to recruit subjects
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Rainbow Light
Intervention Description
2000-3000 IU Vitamin D daily x 6 weeks
Intervention Type
Other
Intervention Name(s)
Placebo candy
Intervention Description
candy gum drops
Primary Outcome Measure Information:
Title
Lessening of musculoskeletal pain level and frequency
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Improvement of serum 25 OH Vitamin D level
Time Frame
6 weeks
Title
Decline of serum parathyroid hormone levels
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ages 5-14
healthy
vague musculoskeletal pain without diagnosis
Exclusion Criteria:
medications (steroids, seizure medications, birth control pills or shot)
endocrinopathies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Szalay, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico General Clinical Research Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children
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