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Chronic Pain and Vitamin D

NCT ID: NCT02002000

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Musculoskeletal Pain Vitamin D Supplementation

Keywords

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Vitamin D deficiency Musculoskeletal pain Vitamin D supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vitamin D

Patients receiving 3 doses of vitamin D (cholecalciferol)

Group Type EXPERIMENTAL

vitamin D (cholecalciferol)

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Placebo, similar in appearance and taste to cholecalciferol

Intervention Type DRUG

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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Marie SCHOTT, Pr

Role: PRINCIPAL_INVESTIGATOR

Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

Locations

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Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

Central Contacts

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Anne-Marie SCHOTT, Pr

Role: CONTACT

Phone: 472115371

Email: [email protected]

Julie Haesebaert

Role: CONTACT

Phone: 472115371

Email: [email protected]

Facility Contacts

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Anne-Marie SCHOTT, Pr

Role: primary

Other Identifiers

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2013-802

Identifier Type: -

Identifier Source: org_study_id