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

NCT03369379 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-06-17

No results posted yet for this study

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 .

Conditions

  • Fibromyalgia
  • D Vitamin Deficiency

Interventions

DRUG

D3 Vitamin

Subjects will receive a capsule of 50,000 units of vitamin D3 echa week for 12 weeks, basal levels of vitamin D will be taken and again at week 12.

OTHER

Placebo

Placebo pill

Sponsors & Collaborators

  • Universidad Autonoma de Nuevo Leon

    lead OTHER

Principal Investigators

  • Mario Alberto Garza Elizondo, Ph D · Hospital Universitario "Dr. José Eleuterio González"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2017-12-31
Completion
2017-12-31
FDA Drug
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369379 on ClinicalTrials.gov