Chronic Pain and Vitamin D

Chronic Musculoskeletal Pain Clinical Trial

— DOVID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02002000
• Other study ID #: 2013-802
• Status: Not yet recruiting
• Phase: N/A
• First received: November 29, 2013
• Last updated: December 9, 2013
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2013
• Source: Hospices Civils de Lyon
• Contact: Anne-Marie SCHOTT, Pr
• Phone: 472115371
• Email: anne-marie.schott-pettelaz[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Chronic Pain
• Musculoskeletal Pain
• Vitamin D Supplementation

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	: 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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No