High-doses of cholecalciferol for vitamin D deficiency treatment: results of an open-label, multicenter, comparative, randomized trial

Background: Vitamin D deficiency have serious medical, social and economic consequences for human health and require timely diagnosis and adequate correction.

Aim: Evaluation of the efficacy and safety of therapy with Fortedetrim soft capsules (MEDANA PHARMA AO, Poland) using saturating and maintenance doses compared to therapy with Vigantol®, an oily solution for oral administration (Merck KGaA, Germany) in patients with vitamin D deficiency.

Materials and methods: The study included 150 patients with vitamin D deficiency (less than 20 ng/ml) aged 18 to 75 years, who were randomized into 3 groups in a 1:1:1 ratio (50 people each). Fortedetrim capsules were used in two groups during the first four weeks 50,000 IU once a week (5 capsules 10,000 IU each) and 56,000 IU — 8,000 IU daily (2 capsules 4000 IU), and Vigantol® was used in the comparison group 1000 IU daily (2 drops). Over the next 12 weeks, patients received supportive therapy — in the first group, Fortedetrim 10,000 IU was used once a week, in the second — Fortedetrim 2,000 IU daily (14,000 IU per week); the comparison group continued to take Vigantol® 1000 IU daily.

Results: As a result of evaluating the data on the results of stages I and II of the clinical study Fortedetrim in comparison with Vigantol®, the hypothesis was proved that the high-dose drug Fortedetrim (capsules of 2000, 4000 and 10000 IU) is superior to the drug Vigantol® (drops, 1000 IU daily). Nevertheless, it should be noted that long-term intake of colecalciferol at a dose of 1000 IU daily by 20 weeks allowed 36% of participants to reach a level of 30 ng/ml, but this is significantly less than in groups using high-dose drugs. There were no differences in the number of adverse events during the study, their degree and the relationship with drug intake between the treatment and comparison groups.

Conclusion: The use of the drug Fortedetrim in saturating doses is effective and safe for the treatment of adult patients with vitamin D deficiency. However, an individual approach to its replenishment is required (taking into account compliance, the degree of obesity, impaired absorption of calcium and vitamin D), since not all patients in the applied saturation regimes, the target values of vitamin D in the blood were reached. 

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