NCT03369379

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

Completed Phase 4 Last updated 17 June 2020

What this trial tests

Phase 4 trial testing D3 Vitamin in Fibromyalgia in 80 participants. Completed in 31 December 2017.

Timeline

31 May 2017

Primary endpoint
31 December 2017

31 December 2017

Quick facts

Lead sponsor	Universidad Autonoma de Nuevo Leon
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	31 May 2017
Primary completion	31 December 2017
Estimated completion	31 December 2017
Sites	1 location across Mexico

Drugs / interventions tested

• D3 Vitamin — full drug profile →
• Placebo

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →
• D Vitamin Deficiency — all drugs for D Vitamin Deficiency →

Sponsor

Universidad Autonoma de Nuevo Leon — full company profile →

Who can join

18 and older, female only, with Fibromyalgia or D Vitamin Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and safety of weekly vitamin D₃ in patients with fibromyalgia: 12-week, double-blind, randomized, controlled placebo trial.
   Lozano-Plata LI, Vega-Morales D, Esquivel-Valerio JA, Garza-Elizondo MA, et al · · 2021 · cited 11× · PMID 33570701 · DOI 10.1007/s10067-021-05640-8