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

This study has been withdrawn prior to enrollment.
(inability to recruit subjects)
Sponsor:
Information provided by (Responsible Party):
Elizabeth Szalay, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00944606
First received: July 21, 2009
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypovitaminosis D
 Dietary Supplement: Vitamin D
Other: Placebo candy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Vitamin D vs Placebo in the Treatment of Vague Musculoskeletal Pain in Children

Resource links provided by NLM:

MedlinePlus related topics: Rickets Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Lessening of musculoskeletal pain level and frequency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of serum 25 OH Vitamin D level [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Decline of serum parathyroid hormone levels [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D Dietary Supplement: Vitamin D
2000-3000 IU Vitamin D daily x 6 weeks
Other Name: Rainbow Light
Placebo Comparator: Placebo Other: Placebo candy
candy gum drops

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • medications (steroids, seizure medications, birth control pills or shot)
  • endocrinopathies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944606

Locations
United States, New Mexico
University of New Mexico General Clinical Research Center
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Elizabeth A Szalay, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Elizabeth Szalay, Professor, Pediatric Orthopaedics & Pediatrics, University of New Mexico
ClinicalTrials.gov Identifier: NCT00944606     History of Changes
Other Study ID Numbers: HRRC 09-167
Study First Received: July 21, 2009
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rickets
Avitaminosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013