Fibromyalgia Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Trial to Measure the Efficacy and Safety of Vitamin D3 in Patients With Fibromyalgia.
Verified date | June 2020 |
Source | Universidad Autonoma de Nuevo Leon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fibromyalgia is a disease that significantly decreases the quality of life of people who suffer from it, has great repercussions at the socio-economic level due to the incapacity it produces. It is characterized by generalized pain, fatigue, sleep disorders, psychological stress and mental alterations, besides presenting painful points in different parts of the body to physical examination. Having few effective treatments is necessary to explore new options in their management to improve the general conditions of the patient. Previous studies have shown that patients with fibromyalgia have had low levels of vitamin D in the blood, a favorable response from post-vitamin D supplementation has been seen. This vitamin has been associated with pain pathways and with increased The perception of the same when it is in smaller amount. We will select patients with Fibromyalgia diagnosis from the external consultation of Rheumatology of the University Hospital "Dr. José Eleuterio González "of the UANL, over 18 years old who have not been previously supplemented with vitamin D, will initially be measured in blood of vitamin D, in addition to calcium as a safety measure, we will have a group that will only receive placebo and Another that will be supplemented with 50 thousand units weekly for 12 weeks, we will apply a questionnaire that measures pain scale and another one that measures the impact of the disease in the daily life of the patient, this will be done in a beginning and at the end of the 12 weeks .
Status | Completed |
Enrollment | 80 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female patients older than 18 years. - Patients who agree to participate in the study. - Those that meet the ACR 1990 and 2010 criteria for Fibromyalgia. - No previous use of vitamin D. - Patients diagnosed with primary or secondary fibromyalgia. Exclusion Criteria: - Those subjects with previous use of vitamin D. - Known subjects with renal, liver, calcium metabolism disorders, malabsorption disorders, known neoplasms. - Subjects with serum calcium levels equal to or greater than 10.2 mg / dl. |
Country | Name | City | State |
---|---|---|---|
Mexico | Universidad Autónoma de Nuevo León | Monterrey | Nuevo León |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Nuevo Leon |
Mexico,
Yong WC, Sanguankeo A, Upala S. Effect of vitamin D supplementation in chronic widespread pain: a systematic review and meta-analysis. Clin Rheumatol. 2017 Dec;36(12):2825-2833. doi: 10.1007/s10067-017-3754-y. Epub 2017 Aug 15. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FIBROMYALGIA IMPACT QUESTIONNAIRE | Number of items in scale: The version from 19911 consisted of 10 items with 10 sub-items in the physical function scale (total items + sub-items = 19). The modified version from 1997 consists of 20 items with 11 physical function items (total items + sub-items = 30). The 2009 version consists of 21 items across the 3 domains of Function (n = 9), Overall Impact (n = 2), and Symptoms (n = 10). Subscales: Subscales from the 1991 version1 include physical function (10 sub-items), feel good (1 item), missed work (1 item), do job (1 item), pain (1 item), fatigue (1 item), rested (1 item), stiffness (1 item), anxiety (1 item), and depression (1 item). |
12 weeks | |
Secondary | VISUAL ANALOGUE SCALE | Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. | 12 weeks |
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