Sponsor study identifier
interventional
80
1 country
1
Study Start
May 31, 2017
Actual (reported)Primary Completion
December 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)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 .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 31, 2017
Actual (reported)July 27, 2017
Actual (reported)December 12, 2017
Actual (reported)December 31, 2017
Actual (reported)December 31, 2017
Actual (reported)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
VISUAL ANALOGUE SCALE
12 weeks
In this group subjects will receive 1 vitamin D3 capsule of 50,000 units, each week, for 12 weeks.
In this group the subjects will receive 1 placebo capsule each week for 12 weeks.
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.
Placebo pill
Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 66460, Mexico
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.
Mario Alberto Garza Elizondo, Ph D
Hospital Universitario "Dr. José Eleuterio González"
80 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2017
First Posted
December 12, 2017
Study Start
Pool-based Exercise in Fibromyalgia Management
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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May 31, 2017
Primary Completion
December 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)Last Updated
June 17, 2020
Record last verified: 2020-06
It will be agreed with all participating researchers.
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Source: ClinicalTrials.gov.
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