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NCT03084328
Vitamin D Replacement in Nonalcoholic Fatty Liver Disease
trial testing Vitamind D in Nonalcoholic Fatty Liver in 48 participants. Completed in 10 March 2017.
20 December 2014
Quick facts
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 48 |
| Start date | 20 January 2012 |
| Primary completion | 20 December 2014 |
| Estimated completion | 10 March 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Vitamind D
Conditions studied
- Nonalcoholic Fatty Liver — all drugs for Nonalcoholic Fatty Liver →
Sponsor
The Cleveland Clinic
Who can join
18 and older, any sex, with Nonalcoholic Fatty Liver. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our observations in the Metabolic Liver Clinic and that reported by others. We also observed that patients with more severe fatty liver disease had lower Vitamin D concentrations. Others have shown that replacing Vitamin D in patients with cirrhosis is effective and even patients with Vitamin D replete status have lowering of Vitamin D over time if not supplemented. One of the measures of liver injury in NAFLD is the plasma concentration of ALT and we will use this to follow patients as is currently done as standard of care. All patients in the Metabolic Liver Clinic are being routinely screened for Vitamin D deficiency as standard of care and treatment is being started with oral supplementation, but there are not standardized protocols to determine success of therapy. We hypothesize that patients with NAFLD with low Vitamin D levels will respond appropriately to Vitamin D supplementation for 6 months.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Addressing the heterogeneity in liver diseases using biological networks.
Lam S, Doran S, Yuksel HH, Altay O, et al · · 2021 · cited 5× · PMID 32201876 · DOI 10.1093/bib/bbaa002
Verify or expand the search:
- PubMed search for NCT03084328
- 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 NCT03084328 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
- Last refreshed: 13 April 2017
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/NCT03084328.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing