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

Primary Purpose

Musculoskeletal Disease Other, Isotretinoin Adverse Reaction, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Isotretinoin
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Musculoskeletal Disease Other focused on measuring D014807, D02.455.326.271.665.202.495.325, C17.800.030.150

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ankara Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isotretinoin-induced adverse effect group

Control group

Arm Description

Patients receiving isotretinoin with dose of 0.5-1 mg/kg/day and had musculoskeletal adverse effects

Pateients receiving isotretinoin with dose of 0.5-1 mg/kg/day had no musculoskeletal adverse effects

Outcomes

Primary Outcome Measures

Musculoskeletal adverse effects in isotretinoin receiving patients
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
Serum 25 hydroxy vitamin D level
serum vitamin d levels will measure in two groups.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2019
Last Updated
December 17, 2019
Sponsor
Ankara Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04204304
Brief Title
Relationship Between Serum Vitamin D Levels and Musculoskeletal Adverse Effects in Patients Using Isotretinoin
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disease Other, Isotretinoin Adverse Reaction, Vitamin D Deficiency
Keywords
D014807, D02.455.326.271.665.202.495.325, C17.800.030.150

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotretinoin-induced adverse effect group
Arm Type
Experimental
Arm Description
Patients receiving isotretinoin with dose of 0.5-1 mg/kg/day and had musculoskeletal adverse effects
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Pateients receiving isotretinoin with dose of 0.5-1 mg/kg/day had no musculoskeletal adverse effects
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Other Intervention Name(s)
Isotretinoin capsules
Intervention Description
ISO
Primary Outcome Measure Information:
Title
Musculoskeletal adverse effects in isotretinoin receiving patients
Description
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
Time Frame
2 days
Title
Serum 25 hydroxy vitamin D level
Description
serum vitamin d levels will measure in two groups.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cevriye Mülkoğlu
Organizational Affiliation
Ankara Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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