DOVID: Chronic Pain and Vitamin D

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT02002000

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

20.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Musculoskeletal Pain Vitamin D Supplementation	Drug: vitamin D (cholecalciferol) Drug: Placebo, similar in appearance and taste to cholecalciferol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Chronic Pain and Vitamin D: a Randomized Pilot Study in General Practice

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vitamin D Patients receiving 3 doses of vitamin D (cholecalciferol)	Drug: vitamin D (cholecalciferol) 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
Experimental: Placebo Patients receiving 3 doses of placebo according to the same schedule as experimental arm	Drug: Placebo, similar in appearance and taste to cholecalciferol 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.

Arm

Intervention/Treatment

Experimental: vitamin D

Patients receiving 3 doses of vitamin D (cholecalciferol)

Drug: vitamin D (cholecalciferol)

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

Experimental: Placebo

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

Drug: Placebo, similar in appearance and taste to cholecalciferol

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.

Outcome Measures

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. [3 months after inclusion]
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 [3 months after inclusion]
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 [3 months after inclusion]
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 [3 months after inclusion]
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) [3 months after inclusion]
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 [3 months after inclusion]
Quality of life will be measured in patients of both groups by the SF-36 questionnaire, at inclusion and after 90 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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