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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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Elizabeth Szalay, University of New Mexico Identifier:
First received: July 21, 2009
Last updated: February 29, 2012
Last verified: February 2012

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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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 Elizabeth Szalay, University of New Mexico:

Primary Outcome Measures:
  • Lessening of musculoskeletal pain level and frequency [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Improvement of serum 25 OH Vitamin D level [ Time Frame: 6 weeks ]
  • Decline of serum parathyroid hormone levels [ Time Frame: 6 weeks ]

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


Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00944606

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
Principal Investigator: Elizabeth A Szalay, MD University of New Mexico
  More Information

Responsible Party: Elizabeth Szalay, Professor, Pediatric Orthopaedics & Pediatrics, University of New Mexico Identifier: NCT00944606     History of Changes
Other Study ID Numbers: HRRC 09-167
Study First Received: July 21, 2009
Last Updated: February 29, 2012

Additional relevant MeSH terms:
Musculoskeletal Pain
Vitamin D Deficiency
Muscular Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Deficiency Diseases
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017