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NCT04915963
Vitamin D Supplementation in Intensive Care Unit Patients
Phase 3 trial testing Vitamin D supplementation in Dietary Supplements in 340 participants. Completed in 30 May 2019.
10 March 2019
Quick facts
| Lead sponsor | Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 340 |
| Start date | 20 January 2016 |
| Primary completion | 10 March 2019 |
| Estimated completion | 30 May 2019 |
Drugs / interventions tested
- Vitamin D supplementation
Conditions studied
- Dietary Supplements — all drugs for Dietary Supplements →
- Intensive Care Unit — all drugs for Intensive Care Unit →
- Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
- Vitamin D Toxicity — all drugs for Vitamin D Toxicity →
Sponsor
Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Who can join
19 and older, any sex, with Dietary Supplements or Intensive Care Unit. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A randomized controlled trial is designed to investigate the safety and clinical efficacy of a mega dose of VD in patients admitted in intensive care unit (ICU). Patients will be randomly allocated to receive 400,000 IU of VD3 or placebo. They will be followed up until ICU discharge or death or the 15th day of ICU stay. Adverse events that occur during ICU stay is collected. Primary outcome is intensive care unit-acquired infection (ICU-AI), and secondary outcomes are septic shock, organ failure, and ICU-mortality. Plasma 25-hydroxyvitamin D is assessed at baseline and at the end of follow-up. Cox regression models will be applied to test how VD supplementation affects adverse outcomes while adjusting for confounders.
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 NCT04915963
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vitamin D supplementation
Trials testing the same drug.
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- NCT05478291 — Vitamin D Supplementation on Surrogate Markers of Atherosclerosis · NA · not yet recruiting
- NCT05650437 — Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women · NA · completed
- NCT05916053 — Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults · NA · completed
- NCT04596657 — Vitamin D3 Supplementation to Prevent Respiratory Tract Infections · NA · completed
Other recruiting trials for Dietary Supplements
Currently open trials in the same condition.
- NCT06379997 — Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies · NA · recruiting
- NCT06138106 — Developing a Nutritional Supplement to Increase Collagen Synthesis in People · NA · recruiting
Other Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose trials
Trials by the same sponsor.
- NCT06538714 — Interval Training and Cardio-metabolic Health in Overweight/Obese Girls · NA · recruiting
- NCT04187885 — Physical Activity Stress and Sleep in Adolescents · NA · unknown
- NCT03799185 — Dyslipidemia Prevalence, Perception, Treatment, and Awareness in the Tunisian Population · completed
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 NCT04915963 (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 Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
- Last refreshed: 18 June 2021
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/NCT04915963.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing