The effect of oral supplementation of zinc on glycemic status, lipid profile and body composition in non-diabetic hemodialysis patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191223045862N1

Enrollment

Registered

2020-03-14

Start date

2019-06-07

Completion date

Unknown

Last updated

2020-03-24

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

Conditions

non-diabetic hemodialysis patients. Chronic kidney disease, stage 5

Interventions

Intervention 1: Intervention group: Daily consumption of a 30 mg tablet of zinc gluconate for 60 days, manufactured by Dineh Iranian Pharmaceutical Company with standard therapy. Intervention 2: Contr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: At least 6 months have passed since the start of hemodialysis. Patients undergo hemodialysis 3 times a week for 4-3 hours. Non-diabetic hemodialysis patients

Exclusion criteria

Exclusion criteria: Patients are candidates for kidney transplant. Patients with any symptoms of gastrointestinal disorders. Patients taking penicillamine medication. Patients taking glucocorticoid medication. Patients taking estrogen medication. Patients taking the antibiotic medication. Women taking oral contraceptives. Patients taking lipid lowering medications. Patients with zinc malabsorption (Acroderma enteropathica). Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
Serum zinc level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum zinc level was measured using Dialab kit by BT-1500 autoanalyzer in micrograms / dL.;Insulin resistance. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Insulin resistance was calculated using the homeostasis model formula (HOMA-IR) as follows. HOMA-IR = [fasting insulin (µU/L) × fasting blood glucose (mg/dl)]/405.	—

Measure

Time frame

Serum zinc level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum zinc level was measured using Dialab kit by BT-1500 autoanalyzer in micrograms / dL.;Insulin resistance. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Insulin resistance was calculated using the homeostasis model formula (HOMA-IR) as follows. HOMA-IR = [fasting insulin (µU/L) × fasting blood glucose (mg/dl)]/405.

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Secondary

Measure	Time frame
Serum albumin level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum albumin levels were measured using Dialab kit by BT-1500 autoanalyzer and in g / dl.;Serum insulin level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum insulin level were measured using Dialab ELISA kit.;Serum glucose level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Glucose level was measured using Pars Co kit and glucose oxidase enzymatic assay.;Total cholesterol concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Total cholesterol concentration was measured using Dialab kit by enzymatic photometry.;LDL-cholesterol concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Dialab kit was used to measure serum LDL-cholesterol concentration.;HDL-cholesterol concentration. Timepoint: Dialab kit was used to measure serum HDL-cholesterol concentration. Method of measurement: At the beginning (day 0) and end of the intervention (day 60).;Serum triglyceride concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum triglyceride concentration was measured using Dialab kit and enzymatically.;Body composition. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: BIA model InBody 770 was used to determine body composition indices.	—

Measure

Time frame

Serum albumin level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum albumin levels were measured using Dialab kit by BT-1500 autoanalyzer and in g / dl.;Serum insulin level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum insulin level were measured using Dialab ELISA kit.;Serum glucose level. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Glucose level was measured using Pars Co kit and glucose oxidase enzymatic assay.;Total cholesterol concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Total cholesterol concentration was measured using Dialab kit by enzymatic photometry.;LDL-cholesterol concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Dialab kit was used to measure serum LDL-cholesterol concentration.;HDL-cholesterol concentration. Timepoint: Dialab kit was used to measure serum HDL-cholesterol concentration. Method of measurement: At the beginning (day 0) and end of the intervention (day 60).;Serum triglyceride concentration. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: Serum triglyceride concentration was measured using Dialab kit and enzymatically.;Body composition. Timepoint: At the beginning (day 0) and end of the intervention (day 60). Method of measurement: BIA model InBody 770 was used to determine body composition indices.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Mohajjel Halim

Oroumia University of Medical Sciences

mohammad.mohajjel.h@gmail.com+98 41 3344 5257

Outcome results

None listed

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