Calcitriol supplementation in Nonalcoholic Fatty Liver Disease

Effect of Calcitriol supplementation on the severity of fatty liver, inflammatory and metabolic biomarkers in patients with non-alcoholic fatty liver with different genotypes of vitamin D receptor

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017053034222N1

Enrollment

160

Registered

2017-06-28

Start date

2017-09-23

Completion date

Unknown

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: 0.25 µg/day calcitriol for 16 weeks. Intervention 2: Calcitriol placebo.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Liver enzymes. Timepoint: Before and after 16 weeks calcitriol treatment. Method of measurement: Activity assay of enzymes in serum.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarges Mohammadtaghvaie

Ahvaz University of Medical Sciences

ntaghvaie@gmail.com+98 61 3373 8317

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 15, 2026