Table 2.
Overview of phase III and phase IV clinical trials currently accessible.
| N. | NCT number | Title | Interventions | Objective | Endpoint/outcome measures | Phase | Allocation | Intervention model | Masking | Total time | Population | Locations | Publications status |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04411862 | Efficacy of phosphatidylcholine in NAFLD | Phosphatidylcholine | To investigate the effectiveness of phosphatidylcholine supplementation, alongside lifestyle modification and patient health education by a clinical pharmacist, in managing NAFLD among adults at risk for metabolic, cardiovascular, and neoplastic complications. |
Primary: 3 and 6-month assessment of BMI, liver stiffness, lipid profile, oxidative stress markers, NAFLD fibrosis score, and insulin resistance. Secondary: Complete blood count changes. |
3 | Randomized | Parallel | None (open label) | Three years and five months | 100 | Egypt | Published |
| 2 | NCT04038853 | Vitamin D in fatty liver disease | 1,25-Dihydroxyvitamin D | To assess the efficacy of vitamin D (Plivit D3) in reducing laboratory, elastographic, and metabolic markers of NAFLD in patients with metabolic syndrome by comparing outcomes between a treatment group and a placebo group. |
Primary: 6 and 12-month changes in steatosis (CAP) and fibrosis (liver stiffness). Secondary: Alterations in hepatic enzymes, insulin resistance, and lipid profile at 6 and 12 months. |
4 | Randomized | Parallel | Quadruple (participant, care provider, investigator, outcomes assessor) | Three years and four months | 360 | Croatia | No publication |
| 3 | NCT02929901 | The effects of coffee main constituents (caffeine and chlorogenic acid) supplementation on inflammatory, metabolic factors, hepatic steatosis, and fibrosis in nonalcoholic fatty liver patients with type 2 diabetes | Caffeine and chlorogenic acid | To evaluate the impact of caffeine and chlorogenic acid supplementation on inflammatory and metabolic markers, hepatic steatosis, and fibrosis in 200 nonalcoholic fatty liver patients with type 2 diabetes. |
Primary: 6-month evaluation of hepatic steatosis via fibroscan CAP.
|
3 | Randomized | Parallel | Quadruple (participant, care provider, investigator, outcomes assessor) | Two years and three months | 200 | Iran | Published |
| 4 | NCT02535195 | Effect of ginger supplement on nonalcoholic fatty liver | Ginger supplement | To investigate the potential of ginger supplementation as a therapeutic strategy for nonalcoholic fatty liver disease by examining its effects on antioxidant activity, inflammation, and insulin resistance. |
Primary: 12-week ALT and AST serum levels. Secondary: 12-week CAP score. |
3 | Randomized | Parallel | Double (participant, investigator) | Two years and five months | 60 | Iran | No publication |
| 5 | NCT02303314 | Efficacy of oral Trigonella Foenum-graecum seed extract vs. placebo in treatment of nonalcoholic fatty liver disease | Trigonella Foenum-graecum seed extract | To evaluate the efficacy of Trigonella foenum-graecum (TFG) in the treatment of NAFLD by comparing its effects to a placebo |
Primary: 12-week liver stiffness change from baseline. |
3 | Randomized | Parallel | Quadruple (participant, care provider, investigator, outcomes assessor) | Two years and ten months | 35 | Iran | No publication |
| 6 | NCT02132442 | Hepatic dysfunction, vitamin D status, and glycemic control in diabetes | Ergocalciferol | To investigate the impact of vitamin D supplementation on glycemic control and liver function in patients with type 2 diabetes, nonalcoholic fatty liver disease, and vitamin D deficiency, and to elucidate the role of vitamin D in the pathogenesis of these comorbidities. |
Primary: 6-month hepatic triglyceride content change (1H MRS). Secondary: 6-month glycemic control (HbA1c). |
3 | Randomized | Parallel | Quadruple (participant, care provider, investigator, outcomes assessor) | Two years and seven months | 12 | United States | No publication |
| 7 | NCT02098317 | DHA and vitamin D in children with biopsy-proven NAFLD | DHA plus vitamin D | To assess the efficacy and tolerability of docosahexaenoic acid (DHA) and vitamin D in pediatric patients with biopsy-proven NAFLD |
Primary: 12-month NAFLD Activity Score improvement. Secondary: 6–12 month lipid and gluco-insulinemic profile changes, treatment safety. |
3 | Randomized | Parallel | Quadruple (participant, care provider, investigator, outcomes assessor) | One year and eight months | 66 | Italy | No publication |
| 8 | NCT01854463 | The effect of vitamin D supplementation on the glycemic control and nonalcoholic fatty liver disease in type 2 diabetes | Vitamin D3 | To investigate the impact of a 2000 IU daily dose of 25-hydroxy vitamin D supplementation, alongside 200 mg of elemental calcium, on glycemic control, nonalcoholic fatty liver disease, arterial stiffness, and bone turnover markers in type 2 diabetes patients compared to a placebo group receiving only 200 mg of elemental calcium. |
Primary: 24-week assessment of non-alcoholic fatty liver diseases and bone turnover marker. |
4 | Randomized | Parallel | Triple (participant, care provider, investigator) | One year and two months | 158 | Korea | Published |
| 9 | NCT01277237 | The effect of Omega-3 fatty acids on nonalcoholic fatty liver disease | OMACOR | To investigate the potential of omega 3 in fish oil to reduce hepatic fat storage and enhance liver function |
Primary: 6-month liver ultrasound appearance. Secondary: 6-month liver function tests, hepatocyte mitochondrial function, and health-related quality of life. |
3 | Randomized | Single Group | Quadruple (participant, care provider, investigator, outcomes assessor) | One year and 11 months | 50 | United Kingdom | No publication |
| 10 | NCT00760513 | Treatment of nonalcoholic fatty liver disease with n-3 fatty acids | OMACOR | To investigate the effects of 18-month long chain n-3 fatty acid supplementation on biomarkers for NAFLD, as well as risk factors for cardiovascular disease and type 2 diabetes in NAFLD patients, through a randomized, double-blind, placebo-controlled trial with OMACOR and placebo oral capsules. |
Primary: 18-month liver fat percentage, liver fibrosis score, and NAFLD fibrosis score. |
4 | Randomized | Parallel | Single (investigator) | Nine years | 103 | United Kingdom | Published |
| 11 | NCT00655018 | Effect of vitamin E on pediatric nonalcoholic fatty liver disease (NAFLD) | Alpha-tocopherol plus ascorbic acid | To investigate the efficacy of lifestyle intervention combined with antioxidant therapy (alpha-tocopherol and ascorbic acid) versus placebo in children and adolescents with biopsy-confirmed NAFLD, assessing changes in liver histology, inflammation, fibrosis, insulin resistance, and glucose metabolism. |
Primary: 12 and 24-month serum aminotransferase levels. Secondary: 24-month liver inflammation and fibrosis. |
2 | Randomized | Parallel | Quadruple (participant, care provider, investigator, outcomes assessor) | Three years | 90 | Italy | Published |
| 12 | NCT00063635 | Treatment of nonalcoholic fatty liver disease in children (TONIC) | Vitamin E and metformin | To investigate the impact of therapeutic interventions targeting insulin resistance and oxidative stress on serum and histologic markers of liver injury and patients’ quality of life. |
Primary: 96-week sustained ALT reduction. Secondary: 96-week changes in AST, NAFLD, BMI, QOL scores; liver fibrosis score, steatosis score, lobular inflammation score, ballooning degradation score. |
3 | Randomized | Parallel | Triple (participant, care provider, investigator) | Four years and five months | 173 | United States | Published |
As of May 1, 2023.