Vitamin D Deficiency Clinical Trial
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
Verified date | December 2019 |
Source | Ankara Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 177 |
Est. completion date | October 1, 2019 |
Est. primary completion date | August 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Training and Research Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Serum 25 hydroxy vitamin D level | serum vitamin d levels will measure in two groups. | 7 days |
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