Status:
COMPLETED
The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules
Lead Sponsor:
Semmelweis University
Collaborating Sponsors:
Pharma Patent Kft.
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Treatment: A: Slower Loading Group (SLD): 30.000 IU cholecalciferol once weekly for ten weeks, followed by 30.000 IU cholecalciferol every two weeks for four weeks. B: Moderate Loading Dose group (ML...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04476511
Start Date
September 5 2018
End Date
December 15 2021
Last Update
March 4 2022
Active Locations (7)
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1
Semmelweis University - Dept. of Medicine and Oncology
Budapest, Hungary, 1083
2
Uno Medical Trials Kft.
Budapest, Hungary, 1135
3
Central Hospital of the Hungarian Homeland Defence Forces
Budapest, Hungary
4
Szalay János Outpatient Clinic
Hajdúnánás, Hungary, 4080