Vitamin-D deficient patients MedDRA version: 20.0 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Pharma Patent Kft.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Trial subjects are in 18-70 years of age. 2. 25(OH)D levels not above of 16 ng/ml by the inclusion 3. Female subjects are under efficient contraception or in postmenopause. 4. The trial subject has the willingness to comply with study procedures and to give voluntary written informed consent signed and dated prior to enrollment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Sever uncontrolled metabolic disease or endocrine disease 2. Significant obesity (BMI> 36) 3. Increased serum calcium level seCa >2.60 mmol/l results or symptoms of hypercalcemia in last year 4. Persistent hypercalciuria or signs of kidney stone in last one year 5. Sever kidney diseases (CKD 3 or higher) 6. Chronic or serious disease, which can significantly influence the absorption, metabolism of bones or vitamin D or Ca 7. Significant absorption disorders that may abolish Ca intake 8. Heart failure or angina pectoris. 9. Signs or suspected alcohol or drug abuse 10. More than 1000 IU per day vitamin D intake within 2 month prior to trial (in any forms medication, or nutritional food supplement) 11. Existence or suspected gravidity 12. Any other finding or symptoms which may indicate a potential interference with the safety by the opinion of the Investigator 13. Has been exposed to any investigational agent within 3 months prior the enrolment to the study 14. Planned travel (>4 days) to a region with high UVB exposure or regular (>2 /month) use of UVB exposition (e.g.solarium) 15. Concomitant medication which is not allowed: • glycosides • Magnesium-containing preparations (antacids) • cholestyramine and other ion exchange resins, orlistat • thiazide diuretics • regular use of microsomal enzyme inducers (anticonvulsants, sedatives, etc.). • corticosteroids (except for dermatological use) • products containing phosphorus • regular use of laxatives (such as paraffin oil) • drugs affecting inhibition on lipid absorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy of the orally administered loading dose schedules of vitamin D3 in deficient patients;Secondary Objective: Assess the efficacy of orally administered loading doses of vitamin D3 by the changes in 25(OH)D levels by the end of 4 weeks maintenance treatment and by the proportion of trial subjects stayed in target range. - Explore the efficacy of maintenance dose of 2000 IU/day equivalent administered biweekly as 30,000 IU tablets - Assess the safety of treatments by the calcium homeostasis (se Ca and urine Ca/creatinine) and the parameters (collagen type 1 cross-linked C-telopeptide, P1NP) of bone turnover in both treatment groups - Assessment during and by the end of treatment on changes in activity, lifestyle and data on risk of fall by study specific tests and questionnaires ;Primary end point(s): The primary efficacy endpoint is the elevation of 25(OH)D levels compared to baseline for each treatment group.;Timepoint(s) of evaluation of this end point: by week 5, week 10 or week 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - the changes in 25(OH)D levels by the end of 4 weeks maintenance treatment and the proportion of trial subjects who reached the target range. - the efficacy of maintenance equivalent dose of 2000 IU/day administered as 30,000 IU tablets biweekly - the proportion of trial subjects who reached and stayed in target range. - Number of AE detected during treatment based on AE profile during treatment periods, by the frequency and distribution during the follow-up and maintenance periods compared between groups. - The comparative safety parameters of treatments by the deviations of calcium homeostasis and the changes in parameters of bone turnover Potential signs in changes in daily activities and the risk of falls based on assessment on changes in activity, lifestyle and data on risk of fall by study specific tests and questionnaires during and by the end of treatment ;Timepoint(s) of evaluation of this end point: by week 5, week 10 or week 15 | — |
Countries
Hungary
Contacts
Public ContactIroda-törzskönyvezés
Pharma Patent Kft
Outcome results
None listed