MedTrace Logo

Acute Effect of Vitamin D3 Supplementation

NCT03849833 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-03-14

No results posted yet for this study

Summary

The investigators have previously completed a clinical trial with long-term vitamin D3 supplementation in healthy humans during a season with negligible ultraviolet B radiation (UVB) in terms of serum 25-hydroxy vitamin D (25(OH)D) increase. In this study (submitted, unpublished), a temporary increase was identified during the first three weeks. Individually, this temporary increase was found in 14 out of 19 participants. This phenomenon has not been described elsewhere in the literature. This could be possible due to less frequent sampling.

The investigators hypothesized that this phenomenon is actual and not an artefact.

The aim of this study was to investigate the serum 25(OH)D increase after short-term vitamin D3 supplementation in a new group of healthy participants with more frequent 25(OH)D sampling. Furthermore, to investigate the influence of sex, age, weight, height, body mass index (BMI), number of fatty fish meals per week, 25(OH)D start level and 30 genetic parameters.

This is a single-centre, open and non-blinded clinical trial. No randomisation was used, as all participants received identical treatment. 25(OH)D sampling was increased from once a week to twice a week. Demographic data (gender, age, weight, height) was collected/measured and registered in prior to study start. The number of daily consumed fatty fish meals was recorded in a questionnaire.

Conditions

  • Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

cholecalciferol, Vitamin D3

Vitamin D3 as dietary supplement

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Hans C Wulf, Professor · Department of Dermatology, D92, Bispebjerg Hospital, 2400 Copenhagen NV, Denmark

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Denmark

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849833 on ClinicalTrials.gov