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Chronic Pain and Vitamin D (DOVID)

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ClinicalTrials.gov Identifier: NCT02002000
Recruitment Status : Unknown
Verified December 2013 by Hospices Civils de Lyon.
Recruitment status was:  Not yet recruiting
First Posted : December 5, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. : Proportion of patients in both groups reporting an evolution of the minimum and the maximum of intensity of pain [ Time Frame: 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

  2. Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities [ Time Frame: 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

  3. Proportion of patients reporting a decrease in the consumption of analgesic drugs [ Time Frame: 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

  4. Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages) [ Time Frame: 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

  5. Proportion of patients in both groups reporting an improvement in quality of life [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002000


Contacts
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Contact: Anne-Marie SCHOTT, Pr 472115371 ext +33 anne-marie.schott-pettelaz@chu-lyon.fr
Contact: Julie Haesebaert 472115371 ext +33 julie.haesebaert@chu-lyon.fr

Locations
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France
Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon Not yet recruiting
Lyon, France, 69424
Contact: Anne-Marie SCHOTT, Pr    4 72 11 53 71 ext +33    anne-marie.schott-pethelaz@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Anne-Marie SCHOTT, Pr Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02002000     History of Changes
Other Study ID Numbers: 2013-802
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Hospices Civils de Lyon:
Vitamin D deficiency
Musculoskeletal pain
Vitamin D supplementation

Additional relevant MeSH terms:
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Chronic Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents