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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Avitaminosis
Musculoskeletal Pain
Rickets
Vitamin D Deficiency
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Deficiency Diseases
Malnutrition
Metabolic Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Nutrition Disorders
Pain
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014