Valuation of Efficacy and Safety of Vitamin D3 Use in 80 Women Diagnosed With Fibromyalgia. Using FIQ Score and VAS.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03369379|
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia D Vitamin Deficiency||Drug: D3 Vitamin Other: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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.|
|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|
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.
- Decrease in FIQ score [ Time Frame: 12 weeks ]Achieve a 20% decrease in baseline FIQ score
- Decrease in VAS [ Time Frame: 12 weeks ]Achieve 20% decrease in baseline VAS score
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
|Contact: Luis Iván Lozano Plata, Dr.||firstname.lastname@example.org|
|Contact: Mario Alberto Garza Elizondo, Ph.D,||email@example.com|
|Universidad Autónoma de Nuevo León||Recruiting|
|Monterrey, Nuevo León, Mexico, 66460|
|Contact: Luis Iván Lozano Plata, Dr. 011528183484830 firstname.lastname@example.org|
|Contact: Mario Alberto Garza Elizondo, Ph.D. 011528180485210 email@example.com|