Overview

Valuation of Efficacy and Safety of Vitamin D3 Use in 80 Women Diagnosed With Fibromyalgia. Using FIQ Score and VAS.

Status:
Completed
Trial end date:
2017-12-31
Target enrollment:
0
Participant gender:
Female
Summary
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 .
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universidad Autonoma de Nuevo Leon
Treatments:
Cholecalciferol
Criteria
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.