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 : Completed
First Posted : December 12, 2017
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia D Vitamin Deficiency||Drug: D3 Vitamin Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual 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|
|Actual Primary Completion Date :||December 31, 2017|
|Actual 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.
- FIBROMYALGIA IMPACT QUESTIONNAIRE [ Time Frame: 12 weeks ]
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).
- VISUAL ANALOGUE SCALE [ Time Frame: 12 weeks ]Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.
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
|Universidad Autónoma de Nuevo León|
|Monterrey, Nuevo León, Mexico, 66460|