NCT03849833

Brief 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 In this study (submitted, unpublished), a temporary increase was identified during the first three weeks.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

February 20, 2019

Last Update Submit

March 13, 2019

Conditions

Healthy Volunteers

Keywords

Vitamin D25(OH)Dvitamin D3 supplementationpigment genes

Outcome Measures

Primary Outcomes (2)

  • Change in serum 25(OH)D

    Serum 25(OH)D is a marker of vitamin D increase induced by vitamin D3 supplementation

    3 weeks

  • Model of increase in serum 25(OH)D

    Model fit of the increase in serum 25(OH)D

    3 weeks

Study Arms (1)

Vitamin D3 supplementation

OTHER

All participants will be selected for treatment with cholecalciferol, vitamin D3 supplementation and included in this single arm

Dietary Supplement: cholecalciferol, Vitamin D3

Interventions

cholecalciferol, Vitamin D3DIETARY_SUPPLEMENT

Vitamin D3 as dietary supplement

Vitamin D3 supplementation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy participants
  • resident in Denmark

You may not qualify if:

  • any supplementary vitamin D intake within three weeks prior to study start
  • use of other supplementary vitamin D than given during the study period;
  • sun holiday south of latitude 45 degree North less than three weeks prior to or during the study period;
  • use of solarium less than three weeks prior to or during the study period;
  • chronic disease;
  • skin disease;
  • intake of cholesterol-lowering medication;
  • pregnancy;
  • drug addiction;
  • psychiatric disorder;
  • physical disabilities;
  • serious adverse events such as hypercalcaemia and nephrolithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, D92, Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

RECRUITING

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Hans C Wulf, Professor

    Department of Dermatology, D92, Bispebjerg Hospital, 2400 Copenhagen NV, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pameli Datta, MD

CONTACT

+45 28763090pameli@mail.dk

Peter A Philipsen, Cand.Scient.

CONTACT

+45 21470893peter.alshede.philipsen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: This is a single-centre, open and non-blinded clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 21, 2019

Study Start

January 31, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Indidividual participant data will be shared if requested at publication.

Locations

DK(1)