The efficacy and the safety of Vitamin D3 30,000 IU for loading dose schedules

Phase 1

• Conditions: Vitamin-D deficient patients; MedDRA version: 20.0Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-000508-40-HU
• Lead Sponsor: Pharma Patent Kft.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-26
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 96

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified