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
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.
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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