NCT00944606

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 1, 2012

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

July 21, 2009

Last Update Submit

February 29, 2012

Conditions

Hypovitaminosis D

Outcome Measures

Primary Outcomes (1)

  • Lessening of musculoskeletal pain level and frequency

    6 weeks

Secondary Outcomes (2)

  • Improvement of serum 25 OH Vitamin D level

    6 weeks

  • Decline of serum parathyroid hormone levels

    6 weeks

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR
Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR
Other: Placebo candy

Interventions

Vitamin DDIETARY_SUPPLEMENT

2000-3000 IU Vitamin D daily x 6 weeks

Also known as: Rainbow Light
Vitamin D
Placebo candyOTHER

candy gum drops

Placebo

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • medications (steroids, seizure medications, birth control pills or shot)
  • endocrinopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico General Clinical Research Center

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Elizabeth A Szalay, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Pediatric Orthopaedics & Pediatrics

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 1, 2012

Record last verified: 2012-02

Locations

US(1)