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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00944606
Recruitment Status : Withdrawn (inability to recruit subjects)
First Posted : July 23, 2009
Last Update Posted : March 1, 2012
Information provided by (Responsible Party):
Elizabeth Szalay, University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Hypovitaminosis D Dietary Supplement: Vitamin D Other: Placebo candy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Elizabeth Szalay, Professor, Pediatric Orthopaedics & Pediatrics, University of New Mexico Identifier: NCT00944606     History of Changes
Other Study ID Numbers: HRRC 09-167
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 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
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents