- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04204304
Relationship Between Serum Vitamin D Levels and Musculoskeletal Adverse Effects in Patients Using Isotretinoin
The Relationship Between Serum 25 Hydroxy Vitamin D Levels and Musculoskeletal Adverse Effects in Patients With Acne Vulgaris Using Isotretinoin: A Cross-sectional Controlled Study
Isotretinoin (ISO) has been used in the treatment of patients with severe acne vulgaris (AV) that is resistant to standard therapy with systemic antibiotics and topical agents, over the last few decades. There are various side effects of ISO in the skeletal system.
This study investigate the relationship between ISO-induced musculoskeletal adverse effects and serum 25 hydroxy (OH) vitamin D levels in patients with acne vulgaris.
Study Overview
Status
Intervention / Treatment
Detailed Description
The rheumatic side effects are the most common one which are musculoskeletal pains and arthralgia, seen over of the 16% patients receiving ISO. Mild, transient myalgias and arthralgias are very common and do not require cessation of the drug. The other musculoskeletal side effects of ISO are calcification of tendon and ligaments, hyperostosis of the spine (DISH syndrome), elevated creatine phosphokinase and cramps. There are many case reports related with ISO-induced sacroiliitis in the literature, mostly recent years.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06230
- Ankara Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ISO at a dose of 0.5-1 mg/kg/day for at least 3 months,
- not to use vitamin D and/or calcium supplements for the last three months
- to be older than 18 years.
Exclusion Criteria:
- Patients who had renal, gastroenteritis, skeletal, psychiatric, hematological, endocrine disorders related with thyroid and bone metabolism
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isotretinoin-induced adverse effect group
Patients receiving isotretinoin with dose of 0.5-1 mg/kg/day and had musculoskeletal adverse effects
|
ISO
Other Names:
|
Active Comparator: Control group
Pateients receiving isotretinoin with dose of 0.5-1 mg/kg/day had no musculoskeletal adverse effects
|
ISO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Musculoskeletal adverse effects in isotretinoin receiving patients
Time Frame: 2 days
|
Locomotor system examination of the participants will perform by the same clinician.The participants were assessed in aspect of musculoskeletal symptoms such as arthralgia, low back pain, calcification of tendon and ligaments, polyneuropathy, hyperostoses of the spine (DISH syndrome), myalgia, cramps and sacroiliitis
|
2 days
|
Serum 25 hydroxy vitamin D level
Time Frame: 7 days
|
serum vitamin d levels will measure in two groups.
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cevriye Mülkoğlu, Ankara Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraTRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin D Deficiency
-
Federal University of Rio Grande do SulCompletedDeficiency, Vitamin DBrazil
-
University Hospital, Clermont-FerrandTerminated
-
Rajavithi HospitalQueen Sirikit National Institute of Child HealthCompleted
-
Universidade de Passo FundoUnknownDeficiency, Vitamin DBrazil
-
Nutrition Institute, SloveniaEuropean Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.CompletedVitamin B 12 Deficiency | Vitamin d Deficiency | Protein DeficiencySlovenia
-
Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionCompletedElderly, Frail | Deficiency, Vitamin DNetherlands
-
University of PaviaIstituti Clinici Scientifici Maugeri SpAUnknownVitamin D Deficiency | Vitamin D3 Deficiency | Vitamin DItaly
-
Okan UniversityArçelik A.Ş.Completed
-
Brigham and Women's HospitalCompletedVitamin d Deficiency
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingVitamin d DeficiencyChina
Clinical Trials on Isotretinoin
-
University of North CarolinaCompleted
-
Cipher Pharmaceuticals Inc.CompletedSevere Nodular AcneUnited States, Canada
-
GlaxoSmithKlineCompleted
-
Mostafa BahaaRecruiting
-
National Institute of Arthritis and Musculoskeletal...Completed
-
Centro Dermatológico Dr. Ladislao de la PascuaNot yet recruiting
-
Kayseri Education and Research HospitalKayseri Erciyes University Faculty of MedicineCompletedAdverse Effects of Medical Drugs
-
SciClone PharmaceuticalsNot yet recruiting
-
Laboratoires Bailleul-BiorgaQuanta MedicalCompletedPapular-pustular Rosacea
-
Shanghai Dermatology HospitalRenJi Hospital; Huadong HospitalUnknown