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NCT05591170
Effect of Single High Dose of Cholecalciferol on Serum Metabolites of Vitamin D
Phase 4 trial testing Cholecalciferol 120 000 IU in Vitamin D Deficiency in 58 participants. Completed in 31 August 2021.
31 August 2021
Quick facts
| Lead sponsor | Department of Endocrinology, Centre of Postgraduate Medical Education |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 58 |
| Start date | 1 April 2021 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Cholecalciferol 120 000 IU — full drug profile →
Conditions studied
- Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
Sponsor
Department of Endocrinology, Centre of Postgraduate Medical Education
Who can join
60 and older, any sex, with Vitamin D Deficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05591170
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05591170 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Department of Endocrinology, Centre of Postgraduate Medical Education
- Last refreshed: 9 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05591170.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing