Determination the effect of calcium and vitamin B12 co-supplementation on some anthropometric indices, blood glucose, lipid profile and blood pressure in Individuals with metabolic syndrome

Determination the effect of calcium and vitamin B12 co-supplementation on some anthropometric indices, blood glucose, lipid profile and blood pressure in Individuals with metabolic syndrome: a randomized triple-blind controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230416057916N1

Enrollment

Registered

2023-11-20

Start date

2023-12-02

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Metabolic syndrome. Metabolic syndrome

Interventions

Intervention 1: Intervention group: In this group, individuals will receive 500 mg of calcium carbonate supplement and 500 mcg of cyanocobalamin (vitamin B12) daily with two main meals for 8 weeks. Th

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Individuals with metabolic syndrome according to ATP III criteria who tend to participate in research Age range of 18-65 years old. Not suffering from kidney, liver, chronic diseases, malignancies, and systemic diseases. Not supplementation of calcium, vitamin B12, chromium, magnesium, and vitamin D for the past 3 months before the study.

Exclusion criteria

Exclusion criteria: pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Serum insulin. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA) kit.;Blood glucose. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Calorimetric Laboratory.;HOMA-IR index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: (Glucose ×insulin)/405.	—

Measure

Time frame

Serum insulin. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA) kit.;Blood glucose. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Calorimetric Laboratory.;HOMA-IR index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: (Glucose ×insulin)/405.

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Secondary

Measure	Time frame
Body Weight. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: scale.;Body mass index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating using the formula with using height and weight.;Waist circumference. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: stadiometer.;Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Digital sphygmomanometer.;Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Digital sphygmomanometer.;Total cholestrol. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method.;Triglyceride. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method.;LDL (low-density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method.;HDL (high-density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method.	—

Measure

Time frame

Body Weight. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: scale.;Body mass index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating using the formula with using height and weight.;Waist circumference. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: stadiometer.;Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Digital sphygmomanometer.;Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Digital sphygmomanometer.;Total cholestrol. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method.;Triglyceride. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method.;LDL (low-density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method.;HDL (high-density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh parastoo Pasban

Shiraz University of Medical Sciences

parastoo_pasban@yahoo.com+98 61 5287 1589

Outcome results

None listed

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