Chronic Musculoskeletal PainDOVIDNCT02002000
Chronic Pain and Vitamin D
A study testing vitamin D (cholecalciferol) in people with Chronic Musculoskeletal Pain and Vitamin D Supplementation, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Musculoskeletal Pain, Vitamin D Supplementation
- What is being tested?
- vitamin D (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
Lyon, 69424
Anne-Marie SCHOTT, Pr, 4 72 11 53 71 ext. +33, anne-marie.schott-pethelaz@chu-lyon.fr
About this study
Official title: 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.
- Being tested
- vitamin D (cholecalciferol), Placebo, similar in appearance and taste to cholecalciferol
- Keywords
- Vitamin D deficiency, Musculoskeletal pain, Vitamin D supplementation
- Medical subject headings
- Vitamin D Deficiency, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D (cholecalciferol)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, similar in appearance and taste to cholecalciferolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Experimental | Patients receiving 3 doses of vitamin D (cholecalciferol) Receives: Drug: vitamin D (cholecalciferol) |
| Placebo | Experimental | Patients receiving 3 doses of placebo according to the same schedule as experimental arm Receives: Drug: Placebo, similar in appearance and taste to cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after inclusion
Secondary outcomes (5)
: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie SCHOTT, Pr, Principal investigator, Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002000
- Sponsor's protocol ID
- 2013-802
- Acronym
- DOVID
- Status last verified
- Dec 2013
- First submitted
- 29 Nov 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain and Vitamin D: a Randomized Pilot Study in General Practice
- ClinicalTrials.gov ID
- NCT02002000
- Acronym / sponsor ID
- DOVID / 2013-802
- Keywords
- Vitamin D deficiency, Musculoskeletal pain, Vitamin D supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Experimental | Drug: vitamin D (cholecalciferol)Patients receiving 3 doses of vitamin D (cholecalciferol) |
| Placebo | Experimental | Drug: Placebo, similar in appearance and taste to cholecalciferolPatients receiving 3 doses of placebo according to the same schedule as experimental arm |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | vitamin D |
| Placebo, similar in appearance and taste to cholecalciferolPatients 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. | Drug | Placebo |
Primary outcome
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
5 secondary outcomes
: 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
Proportion of patients in both groups reporting a decrease in the impact of pain on daily activities
Time frame: 3 months after inclusion
Proportion of patients reporting a decrease in the consumption of analgesic drugs
Time frame: 3 months after inclusion
Proportion of patients in both groups reporting a decrease in the consumption of care (consultations and work stoppages)
Time frame: 3 months after inclusion
Proportion of patients in both groups reporting an improvement in quality of life
Time frame: 3 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Marie SCHOTT, Pr principal investigator
Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D (cholecalciferol) in people with Chronic Musculoskeletal Pain and Vitamin D Supplementation, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Marie SCHOTT, Pr (472115371 ext. +33, anne-marie.schott-pettelaz@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013; AzTrials last refreshed its copy on 29 Oct 2026.