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

NCT03369379 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: RE16-00019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; D Vitamin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• VISUAL ANALOGUE SCALE

  12 weeks

Study Arms (2)

D3 Vitamin

ACTIVE COMPARATOR

In this group subjects will receive 1 vitamin D3 capsule of 50,000 units, each week, for 12 weeks.

Drug: D3 Vitamin

Placebo

PLACEBO COMPARATOR

In this group the subjects will receive 1 placebo capsule each week for 12 weeks.

Other: Placebo

Interventions

D3 Vitamin DRUG

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.

Also known as: D3

D3 Vitamin

Placebo OTHER

Placebo pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women diagnosed with Fibromyalgia from the outpatient clinic of the "Dr. José Eleuterio González" University Hospital of the Autonomous University of Nuevo Leon.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 66460, Mexico

Location

Related Publications (1)

• 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.

  PMID: 28812209 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Mario Alberto Garza Elizondo, Ph D

  Hospital Universitario "Dr. José Eleuterio González"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind, the subject of study and researcher.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Longitudinal, prospective, interventional, randomized.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: December 12, 2017
• Study Start: May 31, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 5 years
• Access Criteria: On request

Locations

ME (1)