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Chronic Pain and Vitamin D (DOVID)

Primary Purpose

Chronic Musculoskeletal Pain, Vitamin D Supplementation

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
vitamin D (cholecalciferol)
Placebo, similar in appearance and taste to cholecalciferol
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Musculoskeletal Pain focused on measuring Vitamin D deficiency, Musculoskeletal pain, Vitamin D supplementation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Women and men
  • Aged 18-50 years (included)
  • Consulting their general practitioner
  • With chronic and diffuse musculoskeletal pain, without known etiology, lasting for at least 3 months
  • With a 25(OH)vitamin D deficiency <20.8 ng/ml (52 nmol/l) at inclusion
  • Who signed the consent form

Exclusion Criteria:

  • Identifiable source of pain requiring an appropriate specific management
  • Disease or treatment that may interfere with the metabolism of vitamin D
  • Current or previous hypercalcemia or hypercalciuria, treatment with digitalics and patients with history of nephrolithiasis
  • Current treatment with vitamin D or at least one vitamin D vial taken over the previous 6 months
  • Pregnancy or breastfeeding
  • not affiliated to a social security system
  • Refusal or inability to give consent

Sites / Locations

  • Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

vitamin D

Placebo

Arm Description

Patients receiving 3 doses of vitamin D (cholecalciferol)

Patients receiving 3 doses of placebo according to the same schedule as experimental arm

Outcomes

Primary Outcome Measures

Proportion of patients in the two groups who reported a decrease in the overall pain after 3 months of treatment with vitamin D versus placebo.
item 5 of the Brief Pain Inventory will be measured in each patient to assess the overall pain score at inclusion and after 3 month of treatment with vitamin D or placebo

Secondary Outcome Measures

: Proportion of patients in both groups reporting an evolution of the minimum and the maximum of intensity of pain
item 3 and 4 of the Brief Pain Inventory will be measured in each patient to assess the minimum and the maximum pain scores at inclusion, after 45 days and after 3 months of treatment with vitamin D or placebo
Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities
item 9 of the Brief Pain Inventory will be measured in each patient to assess the score of the impact of pain on daily activities at inclusion, after 45 days and after 3 months of treatment with vitamin D or placebo
Proportion of patients reporting a decrease in the consumption of analgesic drugs
Patients of both groups will be asked at inclusion, after 45 days and after 3 months, if they took analgesic drugs: name, class and dose of each treatment will be registered in a standardized questionnaire
Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages)
Patients of both groups will be asked at inclusion, after 45 days and after 3 months, if they consulted any health care professional : which health care professional, how many time, the reason for consultation and work stoppages will be registered in a standardized questionnaire
Proportion of patients in both groups reporting an improvement in quality of life
Quality of life will be measured in patients of both groups by the SF-36 questionnaire, at inclusion and after 90 days.

Full Information

First Posted
November 29, 2013
Last Updated
December 9, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02002000
Brief Title
Chronic Pain and Vitamin D
Acronym
DOVID
Official Title
Chronic Pain and Vitamin D: a Randomized Pilot Study in General Practice
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in general practice. The possible causes are numerous and sometimes nonspecific. In some cases, the etiologic investigation of patients with non-systematized and chronic musculoskeletal pain can not highlight any organic cause. Several studies have shown a link between these symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D < 20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D supplementation with few side effects. Nevertheless, it remains unknown and vitamin D deficiency is rarely considered as a possible etiology in patients with chronic pain. We hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal pain and deficient in vitamin D could improve painful symptoms. We aim to perform a double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain improvement after vitamin D supplementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Musculoskeletal Pain, Vitamin D Supplementation
Keywords
Vitamin D deficiency, Musculoskeletal pain, Vitamin D supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin D
Arm Type
Experimental
Arm Description
Patients receiving 3 doses of vitamin D (cholecalciferol)
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Patients receiving 3 doses of placebo according to the same schedule as experimental arm
Intervention Type
Drug
Intervention Name(s)
vitamin D (cholecalciferol)
Intervention Description
Patients from the vitamin D arm will receive an orally supplementation of 600 000 UI cholecalciferol in 3 doses: 200 000 UI at baseline (day 1), 200 000 UI on day 15 and 200 000 UI on day 30. Cholecalciferol will be presented in blisters, in a non-differentiable form in appearance and taste from placebo, either for the patient or the doctor
Intervention Type
Drug
Intervention Name(s)
Placebo, similar in appearance and taste to cholecalciferol
Intervention Description
Patients from the placebo arm will receive 3 doses of placebo to be taken orally: one at baseline (day 1), one on day 15, one on day 30. Placebo will be presented in blisters in a non-differentiable form in appearance and taste from cholecalciferol either for the patient or the doctor.
Primary Outcome Measure Information:
Title
Proportion of patients in the two groups who reported a decrease in the overall pain after 3 months of treatment with vitamin D versus placebo.
Description
item 5 of the Brief Pain Inventory will be measured in each patient to assess the overall pain score at inclusion and after 3 month of treatment with vitamin D or placebo
Time Frame
3 months after inclusion
Secondary Outcome Measure Information:
Title
: Proportion of patients in both groups reporting an evolution of the minimum and the maximum of intensity of pain
Description
item 3 and 4 of the Brief Pain Inventory will be measured in each patient to assess the minimum and the maximum pain scores at inclusion, after 45 days and after 3 months of treatment with vitamin D or placebo
Time Frame
3 months after inclusion
Title
Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities
Description
item 9 of the Brief Pain Inventory will be measured in each patient to assess the score of the impact of pain on daily activities at inclusion, after 45 days and after 3 months of treatment with vitamin D or placebo
Time Frame
3 months after inclusion
Title
Proportion of patients reporting a decrease in the consumption of analgesic drugs
Description
Patients of both groups will be asked at inclusion, after 45 days and after 3 months, if they took analgesic drugs: name, class and dose of each treatment will be registered in a standardized questionnaire
Time Frame
3 months after inclusion
Title
Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages)
Description
Patients of both groups will be asked at inclusion, after 45 days and after 3 months, if they consulted any health care professional : which health care professional, how many time, the reason for consultation and work stoppages will be registered in a standardized questionnaire
Time Frame
3 months after inclusion
Title
Proportion of patients in both groups reporting an improvement in quality of life
Description
Quality of life will be measured in patients of both groups by the SF-36 questionnaire, at inclusion and after 90 days.
Time Frame
3 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women and men Aged 18-50 years (included) Consulting their general practitioner With chronic and diffuse musculoskeletal pain, without known etiology, lasting for at least 3 months With a 25(OH)vitamin D deficiency <20.8 ng/ml (52 nmol/l) at inclusion Who signed the consent form Exclusion Criteria: Identifiable source of pain requiring an appropriate specific management Disease or treatment that may interfere with the metabolism of vitamin D Current or previous hypercalcemia or hypercalciuria, treatment with digitalics and patients with history of nephrolithiasis Current treatment with vitamin D or at least one vitamin D vial taken over the previous 6 months Pregnancy or breastfeeding not affiliated to a social security system Refusal or inability to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Marie SCHOTT, Pr
Phone
472115371
Ext
+33
Email
anne-marie.schott-pettelaz@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Haesebaert
Phone
472115371
Ext
+33
Email
julie.haesebaert@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie SCHOTT, Pr
Organizational Affiliation
Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69424
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie SCHOTT, Pr
Phone
4 72 11 53 71
Ext
+33
Email
anne-marie.schott-pethelaz@chu-lyon.fr

12. IPD Sharing Statement

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Chronic Pain and Vitamin D

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