Calcitriol supplementation in Nonalcoholic Fatty Liver Disease

Phase 3

Recruiting

Conditions: on-Alcoholic Fatty Liver disease (NAFLD).
Fatty (change of) liver, not elsewhere classified

Registration Number: IRCT2017053034222N1

Lead Sponsor: Ahvaz Jundishapur University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

Age between 18- 60 years
Presence of NAFLD diagnosed by Fibroscan elastography
Increased alanine transaminase (> 40 U/L)
BMI below 35

Exclusion Criteria

Alcohol consumption greater than 20 g per day
pregnancy; lactation
viral or autoimmune hepatitis
hereditary hemochromatosis
Wilson's disease
a1-antitripsin deficiency
malabsorption syndromes
consumption of hepatotoxic drugs
high doses of synthetic estrogens
hypothyroidism and Cushing's syndrome
Serum calcium greater than 10.6 mg/dl
history of kidney stones; renal failure
intake of vitamin D, vitamin E and calcium supplements

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iver enzymes. Timepoint: Before and after 16 weeks calcitriol treatment. Method of measurement: Activity assay of enzymes in serum.

Secondary Outcome Measures

Name	Time	Method
Hepatic Steatosis. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: Fibroscan elastography and enzymatic assay of glyceamic and lipid parameters in serum.;High sensitive C-reactive protein (hs-CRP). Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: Enzyme-linked immunosorbent assay.;Total adiponectin. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: Enzyme-linked immunosorbent assay.;Serum leptin. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: Enzyme-linked immunosorbent assay.;Glycemic profile. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: By measuring fasting serum glucose and insulin.;Lipid profile. Timepoint: Before and after 16 weeks of calcitriol treatment. Method of measurement: By enzymatic measurement of fasting serum triglyceride, cholesterol, HDL and LDL.