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Evaluation of the effect of vitamin D supplementation on insulin resistance, lipid profile, thyroid function indices and body composition in overweight and obese patients with hypothyroidism and glucose intolerance

Evaluation of the effect of vitamin D supplementation on insulin resistance, lipid profile, thyroid function indices and body composition in overweight and obese patients with hypothyroidism and glucose intolerance

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210630051751N1
Enrollment
50
Registered
2021-10-11
Start date
2021-10-12
Completion date
Unknown
Last updated
2021-11-01

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

Conditions

Condition 1: Hypothyroidism. Condition 2: Impaired glucose tolerance. Condition 3: Overweight and obesity. Other hypothyroidism Impaired glucose tolerance (oral) Overweight and obesity

Interventions

Intervention 1: Intervention group: For 12 weeks, receive vitamin D3 supplement daily (containing 4000 IU of vitamin D3, produced by Zahravi Pharmaceutical Company). Intervention 2: For 12 weeks, they

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: Individuals between 20 and 75 years old. Overweight or obese individuals with a body mass index above 25. Individuals Suffering from hypothyroidism with TSH levels higher than 7 microIU/ml. Individuals with impaired glucose tolerance with fasting plasma glucose levels above 100 mg/dL or 2-hour plasma glucose above 140 mg / dL. Individuals with serum 25-hydroxyvitamin D3 concentration is less than 30 ng/ml.

Exclusion criteria

Exclusion criteria: Individuals with cancer, kidney, liver, cardiovascular, bone, and endocrine diseases other than hypothyroidism and glucose intolerance disorders. Individuals taking drugs related to diseases such as cancer, kidney, liver, heart, and drugs that affect bone metabolism (estrogen, selective estrogen receptor modulator, bisphosphonate, vitamin D, or calcium). Individuals consuming multivitamins-minerals. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Insulin resistance: A disorder of glucose homeostasis that is defined as a decrease in the sensitivity of adipose tissue, liver, liver, and other body tissues to insulin, despite normal or elevated levels of insulin in the blood. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Using the formula HOMA-IR: [Fasting insulin(mIU/L) × fasting glucose(mg/dL)]/405.

Secondary

MeasureTime frame
Weight: Weight of a person with light minimum possible clothes and without shoes with an accuracy of 100 grams. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Scales.;BMI: [Weight(kg)]/[height (cm) * height (cm)]. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Formula.;Waist Circumference: the smallest circumference of waist in centimeters. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Tape measure.;Serum TSH. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: ELISA.;Serum T3. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: ELISA.;Serum T4. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Eliza.;Fasting serum insulin. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer.;Fasting serum glucose. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer.;HbA1c. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer.;Serum LDL-c. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. Method of measurement: Spectrophotometer.;Serum HDL-c. Timepoint: At the beginning of the study (before the intervention) and 12 weeks later at the end of the intervention. M

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Hassan Eftekhari

Shiraz University of Medical Sciences

H_eftehkari@yahoo.com00988-7251001 3- 071

Outcome results

None listed

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