NCT02002000

Chronic Pain and Vitamin D

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Musculoskeletal Pain
• Vitamin D Supplementation

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-12-05
• Last updated: 2013-12-10

Locations

1 site across 1 country: France