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The effect of vitamin D supplementation in Non Alcoholic Fatty Liver Disease treatment

The effect of vitamin D supplementation on serum hepatic enzymes, oxidative stress indicators & inflammatory markers in patients with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012071810333N1
Enrollment
60
Registered
2012-11-14
Start date
2012-11-21
Completion date
Unknown
Last updated
2018-02-22

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. Fatty (change of) liver

Interventions

Intervention 1: Intervention: One pearl of Vitamin D ( 50000 IU) every other week for 4 months. Intervention 2: Control: Placebo with similarity in physical properties to Vitamin D pearl contains edib
Treatment - Drugs
Intervention: One pearl of Vitamin D ( 50000 IU) every other week for 4 months.
Control: Placebo with similarity in physical properties to Vitamin D pearl contains edible paraffin will be prescribed one every other week for 4 months

Sponsors

Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Diagnosis to have non alcoholic fatty liver disease confirmed with sonography result, ages above 18 and serum alanine transaminase enzyme level higher than normal (> 40 U/L). Diabetic patients will include who have been recently diagnosed with diabetes and not using blood glucose lowering drugs or if they consume insulin and metformin, it would pass at least 6 months from starting the treatment and during this period the dose of metformin and insulin are not changed. Exclusion criteria: Alcohol consumption greater than 20 g per day, pregnancy, lactation, diseases such as hereditary hemochromatosis, Wilson's disease, an enzyme deficiency a1 Antitripsin, history of jejunoileal bypass surgery orgastroplasty, experience to perform the total parenteral nutrition at 6 months before, consomption of hepatotoxic drugs such as calcium channel blocker, high doses of synthetic estrogens, methotrexate, amiodarone, chloroquine, a history of hypothyroidism and Cushing's syndrome. Serum calcium greater than 10.6mg / dl , a history of kidney stones, renal failure, intake of vitamin D,vitamin E and calcium supplements during last 6 months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Alanine Transaminase. Timepoint: Before and after intervention. Method of measurement: U/L - Laboratory kit.;Aspartate transaminase. Timepoint: Before and after intervention. Method of measurement: U/L - Laboratory kit.;Alkaline Phosphatase. Timepoint: before and after intervention. Method of measurement: U/L - laboratory kit.

Secondary

MeasureTime frame
TNF-Alpha. Timepoint: Before and after intervention. Method of measurement: Pg/ml - Laboratory kit.;Insulin Resistance. Timepoint: Before and after intervention. Method of measurement: based on HOMA-IR.;Hs-CRP. Timepoint: Before and after intervention. Method of measurement: Mg/L - Laboratory kit.;Transforming Growth Factor beta (TGF-b). Timepoint: Before and after intervention. Method of measurement: Pg/ml- Laboratory kit.;Cytokeratin-18. Timepoint: Before and after intervention. Method of measurement: U/L - Laboratory kit.;Adiponectin. Timepoint: Before and after intervention. Method of measurement: microgram/ml - laboratory kit.;Malondialdehyde. Timepoint: Before and after intervention. Method of measurement: uM/L- laboratory kit.;Total antioxidant capacity. Timepoint: Before and after intervention. Method of measurement: mM Trolox equivalent- laboratory kit.;Total cholesterol. Timepoint: Before and after intervention. Method of measurement: mg/dl - laboratory kit.;Triglyceride. Timepoint: Before and after intervention. Method of measurement: mg/dl- laboratory kit.;LDL-c. Timepoint: Before and after intervention. Method of measurement: mg/dl - laboratory kit.;HDL-c. Timepoint: Before and after intervention. Method of measurement: mg/dl- laboratory kit.;Serum Vitamin D. Timepoint: Before and after intervention. Method of measurement: ng/ml - laboratory Kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasrin Sharifi

Ahvaz Jundishapur University of Medical Sciences

n_sharifi_nutr@yahoo.com - sharifi.n@ajums.ac.ir+98 61 1373 8317

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026