Chronic Pain and Vitamin D (DOVID)

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

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.

Study Overview

• Status: Unknown
• Conditions: Vitamin D Supplementation; Chronic Musculoskeletal Pain
• Intervention / Treatment: Drug: vitamin D (cholecalciferol); Drug: Placebo, similar in appearance and taste to cholecalciferol

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Marie SCHOTT, Pr; Phone Number: +33 472115371; Email: anne-marie.schott-pettelaz@chu-lyon.fr
• Study Contact Backup: Name: Julie Haesebaert; Phone Number: +33 472115371; Email: julie.haesebaert@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69424
    • Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
    • Contact: Anne-Marie SCHOTT, Pr; Phone Number: +33 4 72 11 53 71; Email: anne-marie.schott-pethelaz@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
: 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	3 months after inclusion
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	3 months after inclusion
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	3 months after inclusion
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	3 months after inclusion
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.	3 months after inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Anne-Marie SCHOTT, Pr, Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): May 1, 2014
• Study Completion (ANTICIPATED): May 1, 2014

Study Registration Dates

• First Submitted: November 29, 2013
• First Submitted That Met QC Criteria: November 29, 2013
• First Posted (ESTIMATE): December 5, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Vitamin D deficiency; Musculoskeletal pain; Vitamin D supplementation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2013-802