Effects of Vitamin D on Inflammation in Liver Disease

Status Recruiting

Clinical Trial Summary

Chronic liver diseases are associated with inflammation. The investigators postulate that Vitamin D may modulate inflammation. Thus the investigators will study the effect of Vitamin D replacement in patients with Hepatitis C infection and Vitamin D deficiency.

Clinical Trial Description

Vitamin D appears to be a critical signaling molecule for macrophages because is needed for activation and differentiation of monocytes/macrophages. From our Preliminary Studies( VA Merit Review Grant), we propose that Vitamin D deficiency may alter the 'pro-inflammatory' ('classically activated') M1 macrophages , characterized by i] high expression of NOS2, TNF-a, IL-1, IL-6, IL-8, TGF-a, CXCL10, and CCL19; and ii] minimal expression of arginase 1 and mannose R.

The clinical relevance of these findings is suggested by the presence of activated M1 macrophages in liver biopsies from patients with severe drug-induced liver injury (unpublished observations).

Prospective vitamin D supplementation studies with appropriate endpoints are needed to define the role of vitamin D on inflammation in patients with chronic liver diseases. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01754961
Study type	Interventional
Source	Veterans Medical Research Foundation
Contact	Kim Inocencio, BS
Phone	619-717-1906
Email	kcinocencio@ucsd.edu
Status	Recruiting
Phase	Phase 2
Start date	November 2011
Completion date	January 2014

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Recruiting	`NCT05459298` - ViDES Trial (Vitamin D Extra Supplementation)	N/A
Completed	`NCT04476511` - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules	Phase 3
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT03920150` - Vitamin D 24'000 IU for Oral Intermittent Supplementation	Phase 3
Completed	`NCT03264625` - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis	Phase 2
Completed	`NCT04183257` - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics	Phase 4
Recruiting	`NCT05084248` - Vitamin D Deficiency in Adults Following a Major Burn Injury	Phase 4
Completed	`NCT05506696` - Vitamin D Supplementation Study	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Completed	`NCT03234218` - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed	`NCT02906319` - Vitamin D and HbA1c Levels in Diabetic Patients With CKD	N/A
Completed	`NCT03203382` - Corneal Nerve Structure in Sjogren's
Completed	`NCT02714361` - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women	N/A
Completed	`NCT02118129` - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.	N/A
Completed	`NCT02187146` - The Effects of Serum Vitamin D and IVF Outcome	N/A
Not yet recruiting	`NCT01419821` - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5	N/A
Completed	`NCT02275650` - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter	N/A
Completed	`NCT01651000` - Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency	Phase 3
Completed	`NCT01741181` - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2	Phase 4