Vitamin D Versus Placebo in the Treatment of Vague Muscul... | NCT00944606

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

NCT00944606

Sponsor

University of New Mexico

Status

Withdrawn

Last Update Posted

Mar 1, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hypovitaminosis D

Interventions

Vitamin D
Placebo candy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inability to recruit subjects

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jul 21, 2009

First Submission Date that Met QC Criteria

Jul 22, 2009

First Posted Date

Jul 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 29, 2012

Last Update Posted Date

Mar 1, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth Szalay, Professor, Pediatric Orthopaedics & Pediatrics, University of New MexicoPrincipal Investigator

Lead Sponsor

University of New MexicoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D	Active Comparator		Dietary Supplement: Vitamin D
Placebo	Placebo Comparator		Other: Placebo candy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Dietary Supplement	2000-3000 IU Vitamin D daily x 6 weeks	Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lessening of musculoskeletal pain level and frequency		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Improvement of serum 25 OH Vitamin D level		6 weeks
Decline of serum parathyroid hormone levels		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ages 5-14
healthy
vague musculoskeletal pain without diagnosis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth A Szalay, MD	University of New Mexico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of New Mexico General Clinical Research Center		Albuquerque	New Mexico	87102	United States

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided