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NCT03849833
Acute Effect of Vitamin D3 Supplementation
NA trial testing cholecalciferol, Vitamin D3 in Healthy Volunteers in 19 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Bispebjerg Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 19 |
| Start date | 31 January 2019 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- cholecalciferol, Vitamin D3
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Bispebjerg Hospital
Who can join
Adults 18 to 85, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 In this study (submitted, unpublished), a temporary increase was identified during the first three weeks.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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03849833
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03849833 (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 Bispebjerg Hospital
- Last refreshed: 14 March 2019
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/NCT03849833.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing