Effect of Single High Dose of Cholecalciferol on Serum Metabolites of Vitamin D

NCT05591170 | Completed Phase 4

• 1 other identifier: 042021082021
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Vitamin D Deficiency

Keywords

vitamin D; 25(OH)D3; 25(OH)D2; 3-epi-25(OH)D3; 24,25(OH)2D3; 1,25(OH)2D3

Outcome Measures

Primary Outcomes (1)

• Changes of serum vitamin D metabolites after the administration of 120 000 IU cholecalciferol compared to control group.

  Changes of 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 the intervention, compared to control group.

  Measurements at baseline, 3 days and 7 days after.

Secondary Outcomes (1)

• Influence of percentage of fat tissue on serum concentration of metabolites of vitamin D and their changes after bolus dose.

  Dual-Energy X-Ray Absorptiometry (DXA) at baseline, measurements of vitamin D metabolites at baseline, 3 days and 7 days after.

Study Arms (2)

Study Group

EXPERIMENTAL

Participants received single, high, oral dose of vitamin D3 (120,000 IU), 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 (measured by LC-MS/MS) at baseline, 3 days and 7 days after bolus dose were measured. The percentage of fat tissue was determined using Dual-Energy X-Ray Absorptiometry (DXA).

Drug: Cholecalciferol 120 000 IU

Control Group

NO INTERVENTION

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 (measured by LC-MS/MS) were measured at baseline, 3 days and 7 days after. The percentage of fat tissue was determined using Dual-Energy X-Ray Absorptiometry (DXA).

Interventions

Cholecalciferol 120 000 IU DRUG

single, oral administration of high dose of vitamin D

Also known as: Solderol

Study Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written, informed consent,
• age ≥ 60 years-old,
• admission to the hospital due to emergency reasons.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Department of Endocrinology, Centre of Postgraduate Medical Education: lead

Study Sites (1)

Department of Endocrinology, Centre of Postgraduate Medical Education

Warsaw, 01-813, Poland

Location

Related Publications (3)

• Ilahi M, Armas LA, Heaney RP. Pharmacokinetics of a single, large dose of cholecalciferol. Am J Clin Nutr. 2008 Mar;87(3):688-91. doi: 10.1093/ajcn/87.3.688.

  PMID: 18326608 BACKGROUND

• Saleh L, Tang J, Gawinecka J, Boesch L, Fraser WD, von Eckardstein A, Nowak A. Impact of a single oral dose of 100,000 IU vitamin D3 on profiles of serum 25(OH)D3 and its metabolites 24,25(OH)2D3, 3-epi-25(OH)D3, and 1,25(OH)2D3 in adults with vitamin D insufficiency. Clin Chem Lab Med. 2017 Oct 26;55(12):1912-1921. doi: 10.1515/cclm-2016-1129.

  PMID: 28328526 BACKGROUND

• Leszczynska D, Szatko A, Kowalski K, Raczkiewicz D, Ostrowska M, Misiorowski W, Zgliczynski W, Glinicki P. The Effect of a Single High Dose of Vitamin D on Serum Levels of Its Metabolites in the Elderly. Front Biosci (Landmark Ed). 2022 Oct 25;27(10):289. doi: 10.31083/j.fbl2710289.

  PMID: 36336861 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Wojciech Zgliczyński, Prof.

  Department of Endocrinology, Centre of Postgraduate Medical Education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: April 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)