NCT01023490

Brief Summary

The objective of this study is to check whether vitamin D will lead to a decrease in pain intensity compare to placebo, in patients suffering from chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

2.8 years

First QC Date

November 30, 2009

Last Update Submit

October 14, 2012

Conditions

Back PainHypovitaminosis D

Keywords

back painhypovitaminosis D

Outcome Measures

Primary Outcomes (1)

  • The objective of this study is to check whether vitamin D will lead to a decrease in pain intensity compare to placebo, in patients suffering from chronic pain.

    one year

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Vitamin D

ACTIVE COMPARATOR

34,500 IU vitamin D per week

Drug: Vitamin D

Interventions

Vitamin DDRUG

34,5000 IU vitamin D per week

Vitamin D
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women over 18, who suffer from chronic pain and hypovitaminosis D

You may not qualify if:

  • patients that are treated with vitamin D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center, Pain Medicine Unit

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Back PainVitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

January 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations

IL(1)