Trial · NCT04198805
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo | Baseline to 6 months | A change in liver fat content relative to baseline between Vitamin E and DHA EE vs placebo. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline). |
| Secondary | Change in Hepatic Fat Fraction [%] Between Vitamin E vs Placebo Arm | Baseline to 6 months | Change in liver fat content relative to baseline between Vitamin E vs placebo arm. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline). |
| Secondary | Change in Hepatic Fat Fraction [%] Between DHA EE vs Placebo Arm | Baseline to 6 months | Change in liver fat content relative to baseline between DHA EE vs placebo arm. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline). |
| Secondary | Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference. | Baseline to 6 months | Evaluation of baseline and 6 month measurements of waist circumference in the DHA EE and /or Vitamin E intervention over a 6 month period. |
| Secondary | Change After 6 Months of DHA EE and /or Vitamin E Intervention in the Anthropometric Measure, Bodyweight. | Baseline to 6 months | Evaluation of baseline and 6-month measurements of body weight in the DHA EE and /or Vitamin E intervention over a 6 month period. |
| Secondary | Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist-to-hip Ratio . | Baseline to 6 months | Evaluation of baseline and 6-month measurements of waist-to-hip ratio (the circumference of the waist divided by the circumference of the hips) in the DHA EE and /or Vitamin E intervention over a 6 month period. |
| Secondary | Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Body Mass Index (BMI) | Baseline to 6 months | Evaluation of baseline and 6-month measurements of body mass index (BMI) in the DHA EE and /or Vitamin E intervention over a 6 month period. |
| Secondary | Change in Insulin Levels to Determine Insulin Resistance | Baseline to 6 months | |
| Secondary | Change in Liver Enzymes (ALT) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period. | Baseline to 6 months | Evaluation of baseline and 6-month liver enzymes: alanine transaminase (ALT) in the DHA EE and /or Vitamin E intervention over a 6 month period value at (6 months minus value at baseline). |
| Secondary | Change in Liver Enzymes (AST) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period. | Baseline to 6 months | Evaluation of baseline and 6-month liver enzymes: aspartate aminotransferase (AST) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Change in Liver Enzymes Bilirubin in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period. | Baseline to 6 months | Evaluation of baseline and 6-month liver enzymes: Bilirubin in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Liver Enzymes Alkaline Phosphatase in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period. | Baseline to 6 months | Evaluation of baseline and 6-month liver enzymes: Alkaline Phosphatase in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Change in Fibrosis-4 (FIB-4) Score | Baseline to 6 months | The formula for FIB-4 is: Age (\[yr\] x AST \[U/L\]) / ((PLT \[10(9)/L\]) x (ALT \[U/L\])(1/2)). A value of FIB-4 below 1.30 is considered as low risk for advanced fibrosis; a value of FIB-4 over 2.67 is considered as high risk for advanced fibrosis |
| Secondary | Change in Plasma Vitamin E Concentration | Baseline to 6 months | Evaluation of baseline and 6-month plasma Vitamin E concentration in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Change in Plasma DHA EE Concentration | Baseline to 6 months | Evaluation of baseline and 6-month plasma DHA EE concentration in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Change in Lipid Profile (HDL-C) | Baseline to 6 months | Evaluation of baseline and 6-month lipid profile (HDL-C) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Change in Lipid Profile (Low Density Lipoprotein (LDL-C)) | Baseline to 6 months | Evaluation of baseline and 6-month lipid profile (low density lipoprotein (LDL-C))in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Change in Lipid Profile (Triglycerides) | Baseline to 6 months | Evaluation of baseline and 6-month lipid profile (TGs)in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Change in Lipid Profile (Oxidized LDL) | Baseline to 6 months | Evaluation of baseline and 6-month lipid profile (oxidized LDL) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). |
| Secondary | Change in Health Related Quality of Life Score (Short Form (SF-36)) | Baseline to 6 months | Evaluation of baseline and 6-month quality of life score (SF-36) in the DHA EE and /or Vitamin E intervention over a 6 month period (value at 6 months minus value at baseline). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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