Relationship Between Serum Vitamin D Levels and Musculoskeletal Adverse Effects in Patients Using Isotretinoin
NCT ID: NCT04204304
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
177 participants
INTERVENTIONAL
2019-03-15
2019-10-01
Brief Summary
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This study investigate the relationship between ISO-induced musculoskeletal adverse effects and serum 25 hydroxy (OH) vitamin D levels in patients with acne vulgaris.
Detailed Description
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The association between ISO and vitamin D levels has been evaluated with several studies in the literature17,18,19. However, the relationship between ISO-induced musculoskeletal side effects in AV patients and serum vitamin D levels has not been investigated until now. To the best our knowledge, this is the first study to evaluate the relationship between the serum vitamin D levels and the musculoskeletal side effects related with ISO in AV patients.
In this study, 87 patients receiving ISO for AV and had ISO-induced musculoskeletal side effects, were enrolled as adverse effect (AE) group. The control (C) group was consisted of age- and sex-matched 90 consecutive patients using ISO but had no musculoskeletal symptoms.
The participants was assessed in aspect of musculoskeletal symptoms such as arthralgia, low back pain, calsification of tendon and ligaments, polyneuropathy, hyperostoses of the spine (DISH syndrome), myalgia, cramps and sacroiliitis. It was queried that whether myalgia, arthralgia, low back pain or sacroiliitis has occurred after ISO treatment. Serum 25 (OH) vitamin D levels were measured in all participants. According to these results, patients in AE group were divided into three subgroups in aspect of the serum vitamin D levels. Patients with serum 25 (OH) vitamin D level is lower than 10 ng/ml, was recruited as Group I, between 10-20 ng/ml, as Group II, higher than 20 ng/ml as Group III.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Isotretinoin-induced adverse effect group
Patients receiving isotretinoin with dose of 0.5-1 mg/kg/day and had musculoskeletal adverse effects
Isotretinoin
ISO
Control group
Pateients receiving isotretinoin with dose of 0.5-1 mg/kg/day had no musculoskeletal adverse effects
Isotretinoin
ISO
Interventions
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Isotretinoin
ISO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* not to use vitamin D and/or calcium supplements for the last three months
* to be older than 18 years.
Exclusion Criteria
* Patients receiving drugs such as diuretics, multivitamins, anticonvulsants, glucocorticoids, erythromycin, estrogen compound pills, alcohol, vitamin D and/or calcium preparats in the last three months,
* Malignancy,
* Chronic liver and kidney failure,
* History of psoralen and ultraviolet A (PUVA)
* Women waiting pregnancy.
18 Years
ALL
Yes
Sponsors
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Ankara Training and Research Hospital
OTHER
Responsible Party
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Cevriye Mülkoğlu
Director, clinical research
Principal Investigators
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Cevriye Mülkoğlu
Role: PRINCIPAL_INVESTIGATOR
Ankara Training and Research Hospital
Locations
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Ankara Training and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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AnkaraTRH
Identifier Type: -
Identifier Source: org_study_id