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

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ClinicalTrials.gov Identifier: NCT03369379
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 .

Condition or disease Intervention/treatment Phase
Fibromyalgia D Vitamin Deficiency Drug: D3 Vitamin Other: Placebo Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Longitudinal, prospective, interventional, randomized.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind, the subject of study and researcher.
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Trial to Measure the Efficacy and Safety of Vitamin D3 in Patients With Fibromyalgia.
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: D3 Vitamin
In this group subjects will receive 1 vitamin D3 capsule of 50,000 units, each week, for 12 weeks.
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 Name: D3
Placebo Comparator: Placebo
In this group the subjects will receive 1 placebo capsule each week for 12 weeks.
Other: Placebo
Placebo pill


Outcome Measures

Primary Outcome Measures :
  1. Decrease in FIQ score [ Time Frame: 12 weeks ]
    Achieve a 20% decrease in baseline FIQ score


Secondary Outcome Measures :
  1. Decrease in VAS [ Time Frame: 12 weeks ]
    Achieve 20% decrease in baseline VAS score


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women diagnosed with Fibromyalgia from the outpatient clinic of the "Dr. José Eleuterio González" University Hospital of the Autonomous University of Nuevo Leon.
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369379


Contacts
Contact: Luis Iván Lozano Plata, Dr. 011528183484830 ivanlozano40@gmail.com
Contact: Mario Alberto Garza Elizondo, Ph.D, 011528180485210 mariogarz@hotmail.com

Locations
Mexico
Universidad Autónoma de Nuevo León Recruiting
Monterrey, Nuevo León, Mexico, 66460
Contact: Luis Iván Lozano Plata, Dr.    011528183484830    ivanlozano40@gmail.com   
Contact: Mario Alberto Garza Elizondo, Ph.D.    011528180485210    mariogarz@hotmail.com   
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
More Information

Publications:
Responsible Party: Luis Ivan Lozano Plata, Dr., Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03369379     History of Changes
Other Study ID Numbers: RE16-00019
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It will be agreed with all participating researchers.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Luis Ivan Lozano Plata, Universidad Autonoma de Nuevo Leon:
Fibromyalgia
D Vitamin

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Avitaminosis
Vitamin D Deficiency
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents