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Relationship Between Serum Vitamin D Levels and Musculoskeletal Adverse Effects in Patients Using Isotretinoin

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ClinicalTrials.gov Identifier: NCT04204304
Recruitment Status : Completed
First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Cevriye Mülkoğlu, Ankara Training and Research Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Musculoskeletal Disease Other Isotretinoin Adverse Reaction Vitamin D Deficiency Drug: Isotretinoin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : March 15, 2019
Actual Primary Completion Date : August 15, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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
Drug: Isotretinoin
ISO
Other Name: Isotretinoin capsules

Active Comparator: Control group
Pateients receiving isotretinoin with dose of 0.5-1 mg/kg/day had no musculoskeletal adverse effects
Drug: Isotretinoin
ISO
Other Name: Isotretinoin capsules




Primary Outcome Measures :
  1. 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. Serum 25 hydroxy vitamin D level [ Time Frame: 7 days ]
    serum vitamin d levels will measure in two groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT04204304


Locations
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Turkey
Ankara Training and Research Hospital
Ankara, Turkey, 06230
Sponsors and Collaborators
Ankara Training and Research Hospital
Investigators
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Principal Investigator: Cevriye Mülkoğlu Ankara Training and Research Hospital
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Responsible Party: Cevriye Mülkoğlu, Director, clinical research, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04204304    
Other Study ID Numbers: AnkaraTRH
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cevriye Mülkoğlu, Ankara Training and Research Hospital:
D014807
D02.455.326.271.665.202.495.325
C17.800.030.150
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Isotretinoin
Dermatologic Agents