Studying the effect of vitamin D3 on insulin resistance and liver fibrosis index in patients with vitamin D deficiency

Studying the effect of vitamin D3 administration on insulin resistance and liver fibrosis index (FIB-4) in patients with vitamin D deficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260129068694N1

Enrollment

Registered

2026-02-14

Start date

2026-02-20

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Condition 1: Liver fibrosis. Condition 2: Insulin resistance. Fibrosis and cirrhosis of liver Insulin resistance

Interventions

Intervention group: Patients with vitamin D deficiency:61 patients with vitamin D deficiency will be selected through simple random sampling. Participants will receive an injectable dose of 600,000 mg

Eligibility

Sex/Gender

All

Age

25 Years to 65 Years

Inclusion criteria

Inclusion criteria: Vitamin D deficiency (baseline serum 25-hydroxyvitamin D level below 30 ng/dL) BMI between 25 and 29.9 kg/m2

Exclusion criteria

Exclusion criteria: Having severe liver disease Hx having type2 DM having alcoholic fatty liver disease having hepatitis C having Wilson's disease pregnant women's with acute fatty liver drug-induced fatty liver and kidney disease having cancers and malignancies other conditions such as taking lipid-lowering drugs and treating obesity or fatty liver

Design outcomes

Primary

Measure	Time frame
HOMA-IR scores changes. Timepoint: Measurement of changes in HOMA-IR scores at the beginning of the study (before the intervention) and 4 months after starting vitamin D intake. Method of measurement: Insulin resistance index (HOMA-IR) will be calculated as a computational index. This index will be calculated based on measurements of fasting plasma glucose (mg/dL) and fasting serum insulin (µIU/mL) from the laboratory results report, using the standard HOMA -IR formula and will be recorded in the structured data collection form.;FIB-4score. Timepoint: at the beginning of the study (before the intervention) and 4 months after starting vitamin D intake. Method of measurement: The data required for calculating FIB-4 including (AST, ALT and platelet count) will be extracted from the laboratory results report and the FIB-4 index will calculated. Finally, these values will be recorded in the structured data collection form. then this values will be entered in the structured data collection form.	—

Measure

Time frame

HOMA-IR scores changes. Timepoint: Measurement of changes in HOMA-IR scores at the beginning of the study (before the intervention) and 4 months after starting vitamin D intake. Method of measurement: Insulin resistance index (HOMA-IR) will be calculated as a computational index. This index will be calculated based on measurements of fasting plasma glucose (mg/dL) and fasting serum insulin (µIU/mL) from the laboratory results report, using the standard HOMA -IR formula and will be recorded in the structured data collection form.;FIB-4score. Timepoint: at the beginning of the study (before the intervention) and 4 months after starting vitamin D intake. Method of measurement: The data required for calculating FIB-4 including (AST, ALT and platelet count) will be extracted from the laboratory results report and the FIB-4 index will calculated. Finally, these values will be recorded in the structured data collection form. then this values will be entered in the structured data collection form.

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Secondary

Measure	Time frame
Fasting plasma glucose (FPG). Timepoint: at the beginning of the study (before the intervention) and 4 months after starting vitamin D intake. Method of measurement: Fasting plasma glucose will be measured using an automated analyzer and the enzymatic glucose oxidase method on a venous blood sample taken after 10-12 hours of fasting. The results will be extracted via a laboratory reports and recorded in a structured data collection form.;Fasting serum insulin:. Timepoint: at the beginning of the study (before the intervention) and 4 months after starting vitamin D intake. Method of measurement: Fasting serum insulin: will be measured from the patient's blood sample taken at the center's laboratory according to sampling protocols using an immunochemical ELISA with electrochemiluminescence detection (ECLIA). The results will be extracted from the laboratory report and recorded in a structured data collection form.	—

Measure

Time frame

Fasting plasma glucose (FPG). Timepoint: at the beginning of the study (before the intervention) and 4 months after starting vitamin D intake. Method of measurement: Fasting plasma glucose will be measured using an automated analyzer and the enzymatic glucose oxidase method on a venous blood sample taken after 10-12 hours of fasting. The results will be extracted via a laboratory reports and recorded in a structured data collection form.;Fasting serum insulin:. Timepoint: at the beginning of the study (before the intervention) and 4 months after starting vitamin D intake. Method of measurement: Fasting serum insulin: will be measured from the patient's blood sample taken at the center's laboratory according to sampling protocols using an immunochemical ELISA with electrochemiluminescence detection (ECLIA). The results will be extracted from the laboratory report and recorded in a structured data collection form.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNosratolah Alizadeh

Shahid Beheshti University of Medical Sciences

alizadehnosratolah052@gmail.com+98 21 7343 2385

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026