Treatment of hypovitaminosis D with pharmacologic doses of cholecalciferol, oral vs intramuscular; an open labeled RCT.

OBJECTIVE: Vitamin D deficiency is a worldwide health problem. Usual supplements are inadequate for prevention of hypovitaminosis D, and much higher doses are needed for its treatment. This study was designed to compare the efficacy and practicality of high-dose intramuscular and oral cholecalciferol in treatment of hypovitaminosis D and to evaluate durability of the effect of each remedy. DESIGN: Ninety-two patients with hypovitaminosis D [serum 25(OH) D level < 75 nmol/l] were enrolled in a randomised clinical trial. Participants were randomly assigned to receive 300 000 IU cholecalciferol, either intramuscularly as a single injection or orally in six divided doses during 3 months period. Serum 25(OH) D level was measured at baseline and at 3 and 6 months. RESULTS: Both treatment regimens significantly increased the serum 25(OH)D level. Delta change in serum 25(OH) D level from baseline (presented as mean ± SEM) at month 3 was significantly higher in oral than injection group (90 ± 11·2 and 58·8 ± 8·9 nmol/l, respectively, P = 0·03); but was similar at 6th month intervention (52·1 ± 7·6 and 62·2 ± 6·7 nmol/l, respectively, P = 0·32). There was a marginally significant trend in favour of oral group in the proportion of cases attained vitamin D adequacy at 6th month (P = 0·06); but still 15% of all patients remained at < 50 nmol/l. CONCLUSION: Both regimens were considerably effective, safe and practical in treating hypovitaminosis D. Although we revealed superiority of oral route, at least at early short time, the way of treatment may depend on the patient's choice, compliance and availability of various forms of the drug in any regions.

Role of Omega-3 fatty acids in preventing metabolic disturbances in patients on olanzapine plus either sodium valproate or lithium: a randomized double-blind placebo-controlled trial.

BACKGROUND: Metabolic and cardiovascular side effects have been noted with the use of second generation antipsychotics (SGAs) and mood stabilizers. Since Omega-3 fatty acids have been known to prevent some cardiovascular risks, this preliminary study was designed to evaluate the cardiovascular benefits of omega-3 when added to the combinations of olanzapine with mood stabilizers. METHODS: This study was a randomized, double-blind, placebo-controlled, within-subject trial in adult psychiatric patients who were receiving olanzapine combined with lithium (Li) or valproate sodium (VPA). Omega-3 as fish oil with less than 1 g/day of EPA/DHA or its placebo was added to patients' olanzapine and mood stabilizer regimens for 6 weeks. Metabolic parameters including anthropometric variables, lipid profile, metabolic syndrome indices, C-reactive protein, fibrinogen and lipoprotein (a) [(Lp) (a)] were assessed for participants. RESULTS: Forty one participants completed this study; 20 patients received omega-3 and 21 patients received placebo, added to their regimen of SGA and mood stabilizer. Omega-3 addition did not modulate anthropometric, metabolic syndrome and lipid parameter changes in 6 weeks. However, fibrinogen levels significantly decreased, Lp (a) did not increase and non-high-density lipoprotein cholesterol (non-HDL-C) did not go beyond its target level after omega-3 supplementation. Additionally, a significant inter-group effect was noted for Lp(a). CONCLUSIONS: This study suggests that use of short-term omega-3 supplementation added to a combined regimen of olanzapine and mood stabilizer may have a small modulating effect on some cardiovascular risk factors. Trials in longer periods of time and with larger number of patients are needed to further evaluate the effects of omega-3 supplements on preventing cardiovascular risk factors.This trial is registered at irct.ir and its Identifier is as following: IRCT138712231764N1.

Outbreak of exogenous Cushing's syndrome due to unlicensed medications.

OBJECTIVE: Despite the widespread medical use of glucocorticoids, reports of factitious administration of these hormones have been uncommon. We herein report an outbreak of Cushing's syndrome in Tehran among the addicts using Tamgesic (a brand of Buprenorphine) to help them through the narcotic withdrawal stage, without knowledge of the glucocorticoid content of the black-market drug. DESIGN AND MEASUREMENTS: Case histories of 19 patients with a final diagnosis of iatrogenic Cushing's syndrome were reviewed. Liquid chromatography/mass spectrometry (LC-Mass) method was used to evaluate glucocorticoid existence in the brand. High performance liquid chromatography was used to determine plasma dexamethasone level. RESULTS: No buprenorphine was present in the vials. Each Tamgesic vial contained 0.4 mg of Dexamethasone disodium phosphate; Heroin was also found in them. The duration of injection abuse and the total dexamethasone intake was 4.5 (1-18) months and 2.6 (0.8-8) mg/day, respectively. Median plasma dexamethasone concentration was 5.8 nmol/l, with a range of 5-8.7. Physical findings of the cases were not different from those of the classic endogenous Cushing's syndrome but their serum cortisol and urinary free cortisol were suppressed. Severe life-threatening complications were demonstrated in five cases. CONCLUSION: Surreptitious use of steroids resulting in Cushing's syndrome may be more common in opium addicts; a high degree of suspicion is needed to uncover this disorder. Whenever facing a cushingoid appearance in addicts, the possibility of using black market drugs with corticosteroid contents should be kept in mind.