The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules

Launched by SEMMELWEIS UNIVERSITY · Jul 14, 2020

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Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 70 years
• • 25OHD level is no more than 16 ng/ml
• • Postmenopausal state or adequate contraception in female patients
• • Willing and able to give legal informed consent for study entry
• Exclusion Criteria:
• • Severe endocrine or metabolic disease, significant metabolic bone disease (except primary age-related osteoporosis)
• • significant obesity (BMI \>36 kg/m2)
• • hypercalcemia at screening or within one year (seCa \> 2.60 mmol/l)
• • long standing hypercalciuria, kidney stones within 2 years
• • sever kidney injury (KDIGO CKD 3 or more)
• • chronic disease which significantly affects bone metabolism, vitamin D metabolism or calcium absorption
• • significant malabsorption that affects calcium metabolism
• • heart failure or angina pectoris
• • alcohol or drug abuse
• • daily vitamin D intake is more than 1000 IU within 2 months
• • suspected or proved pregnancy
• • any other symptoms or findings which may interact with the safety of the study drug, evaluated by investigator
• • participating in other clinical trial within 3 months of study entry
• • planned journey to geographic location with high natural UV-B exposition for mor than 4 days during the study or regular (more than 2 times per month) artificial UV-B exposition (eg. sun parlor)
• * Taking prohibited medication:
• • glycosides
• • magnesium containing medications (eg. antacids)
• • cholestyramine and other ion exchange resins, orlistat
• • thiazide type diuretics
• • microsomal enzyme inductors (eg. anticonvulsants, sedatives)
• • corticosteroids
• • phosphates
• • laxatives
• • medications decreasing lipid absorption