Effect of vitamin D, vitamin D + calcium supplementation on nonalcoholic fatty liver disease

The effect of vitamin D supplementation, vitamin D + calcium on fat storage in liver, serum lipoproteins and insulin sensitivity in patients with non-alcoholic fatty liver disease compared with controls.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201408312709N29

Enrollment

Registered

2014-10-11

Start date

2014-11-22

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

Nonalcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Placebo: two tablets contain lactose, produced in the company of jalinus, once daily, for 12 weeks. Intervention 2: Intervention: Vitamin D tablets. Contains 1000 international units o

Placebo

Treatment - Drugs

Placebo: two tablets contain lactose, produced in the company of jalinus, once daily, for 12 weeks.

Intervention: Vitamin D tablets. Contains 1000 international units of vitamin D, produced in the company of jalinus, once daily, for 12 weeks.

Intervention: One tablet contains 1000 international units of vitamin D + one tablet containing 500 mg of calcium, produced in the company of jalinus, once daily, for 12 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Willingness to participate in this clinical trial, do not consume alcohol, not smoking, age 18 to 65 Years, BMI less than 35 (kilograms by the square of height), not taking certain medications (hepatotoxic drugs such as phenytoin, amiodarone, levothyroxine), not having these diseases (diabetes, heart, liver, kidney, lung), Not having inherited disorders affecting the liver (iron and copper storage disease, etc), not professional athlete, avoiding the use of nutritional supplements in the past 3 months. Exclusion criteria: Unwillingness to cooperate, taking nutritional supplements, pregnancy or lactation, smoking, alcohol consumption, intake of less than 70% of prescribed pills.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
CH. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: END POINT enzymatic method.;Liver Fat. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Measured by ultrasound (normal - mild - moderate - severe).;Hip circumference. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: By measuring tape.;Percent body fat. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: BIA.;HDL. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: DIRECT enzymatic method.;LDL. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Using the Fried Wald Equation.;TG. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: END POINT enzymatic method.;FBS. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Glucose oxidase enzymatic colorimetric method.;Fasting insulin. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: By ELISA (IRMA).;Weight. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Scales.;BMI. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Measured height and weight.;Waist. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: tape.	—

Measure

Time frame

CH. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: END POINT enzymatic method.;Liver Fat. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Measured by ultrasound (normal - mild - moderate - severe).;Hip circumference. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: By measuring tape.;Percent body fat. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: BIA.;HDL. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: DIRECT enzymatic method.;LDL. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Using the Fried Wald Equation.;TG. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: END POINT enzymatic method.;FBS. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Glucose oxidase enzymatic colorimetric method.;Fasting insulin. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: By ELISA (IRMA).;Weight. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Scales.;BMI. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Measured height and weight.;Waist. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: tape.

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Secondary

Measure	Time frame
Vitamin D supplement. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Questionnaire.;Placebo. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Questionnaire.;Age. Timepoint: before the experiment. Method of measurement: Questionnaire.;Height. Timepoint: before the experiment. Method of measurement: Tape.;Energy intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Protein intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Carbohydrate intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Fat intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Cholesterol intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Vitamin E intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Vitamin C intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Vitamin A intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Omega3 intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Calcium intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the	—

Measure

Time frame

Vitamin D supplement. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Questionnaire.;Placebo. Timepoint: before the experiment.12 weeks after intervention. Method of measurement: Questionnaire.;Age. Timepoint: before the experiment. Method of measurement: Questionnaire.;Height. Timepoint: before the experiment. Method of measurement: Tape.;Energy intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Protein intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Carbohydrate intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Fat intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Cholesterol intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Vitamin E intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Vitamin C intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Vitamin A intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Omega3 intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the intervention. Method of measurement: 24-hour recall questionnaire.;Calcium intake. Timepoint: before the experiment, 6 weeks after the intervention, 12 weeks after the

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Lorvand Amiri

Iran University of Medical Sciences

lorvandhamid@gmail.com+98 21 8862 2706

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 12, 2026