Clinical trial
The Effect of Single High Dose of Vitamin D on Serum Levels of Its Metabolites
Name
042021082021
Description
The aim of this interventional study is to assess the effect of the single high dose of vitamin D on its serum metabolites in elderly.
The main questions it attempts to answer is:
1. what is the effect of a single, high, oral dose of vitamin D3 (120,000 IU) on serum 25(OH)D3, 25(OH)D2, 24,25(OH)2D3, 3-epi-25(OH)D3, 1,25(OH)2D3, 24,25(OH)2D3/25(OH)D3 ratio, and 25(OH)D3/3-epi-25(OH)D3 ratio concentration at baseline, 3 days and 7 days after administration, compared to control group.
2. what is the influence of percentage of fat tissue on serum metabolites of vitamin D and their changes after bolus dose, compared to control group.
Trial arms
Trial start
2021-04-01
Estimated PCD
2021-08-31
Trial end
2021-08-31
Status
Completed
Phase
Early phase I
Treatment
Cholecalciferol 120 000 IU
single, oral administration of high dose of vitamin D
Arms:
Study Group
Other names:
Solderol
Size
58
Primary endpoint
Changes of serum vitamin D metabolites after the administration of 120 000 IU cholecalciferol compared to control group.
Measurements at baseline, 3 days and 7 days after.
Eligibility criteria
Inclusion Criteria:
* written, informed consent,
* age ≥ 60 years-old,
* admission to the hospital due to emergency reasons.
Exclusion Criteria:
* hypercalcemia,
* nephrolithiasis,
* kidney insufficiency,
* documented vitamin D3 metabolism disorders such as sarcoidosis, parathyroid disease or genetic defects,
* vitamin D3 supplementation within 6 months prior to the hospitalisation.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}
Updated at
2023-02-09
1 organization
1 product
1 indication
Product
CholecalciferolIndication
Vitamin D Deficiency