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

NCT04204304 | Completed DMC

• 1 other identifier: AnkaraTRH
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Disease Other; Isotretinoin Adverse Reaction; Vitamin D Deficiency

Keywords

D014807; D02.455.326.271.665.202.495.325; C17.800.030.150

Outcome Measures

Primary Outcomes (2)

• 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

  2 days

• Serum 25 hydroxy vitamin D level

  serum vitamin d levels will measure in two groups.

  7 days

Study Arms (2)

Isotretinoin-induced adverse effect group

EXPERIMENTAL

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

Drug: Isotretinoin

Control group

ACTIVE COMPARATOR

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

Drug: Isotretinoin

Interventions

Isotretinoin DRUG

ISO

Also known as: Isotretinoin capsules

Control group; Isotretinoin-induced adverse effect group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Cevriye Mülkoğlu

  Ankara Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, clinical research

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 18, 2019
• Study Start: March 15, 2019
• Primary Completion: August 15, 2019
• Study Completion: October 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)