The effect of oral "zinc" supplementation on the T cells reconstitution in patients undergoing autologous hematopoietic stem cell transplantation

Comparison of oral zinc supplement and placebo effect in improving the T cells regeneration in patients undergoing autologous hematopoietic stem cell transplantation-clinical trial study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191211045701N1

Enrollment

Registered

2020-06-12

Start date

2022-06-22

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Patients with multiple myeloma who are candidates for stem cell transplantation.. Other and unspecified malignant neoplasms of lymphoid, hematopoietic and related tissue

Interventions

Intervention 1: Intervention group: Patients who underwent autologous HSCT receive three tablets of "gluconate zinc" (each tablet containing 30 mg zinc elemental) daily after eating main meals for fi

Eligibility

Sex/Gender

All

Age

40 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age range 40 to 60 years Patients with a history of multiple myeloma on complete response to treatment Patients are candidates for autologous hematopoietic stem cell transplantation Confirmation of the patient's heart, kidney, liver, lung, and digestive system health before hematopoietic stem cell transplantation by a specialist

Exclusion criteria

Exclusion criteria: History of sensitivity to "zinc" oral supplement Patients who have taken oral supplements for three months before transplantation. Serum levels above 200 mg/dl

Design outcomes

Primary

Measure	Time frame
Number of Recent Thymic Emigrant T-cells in peripheral blood mononuclear cells (PBMC). Timepoint: Before hematopoietic stem cell transplantation begging and 30, 90, 180 days after transplantation. Method of measurement: Using flow cytometry technique and specific RET T cells markers.;Determination of copy number of TREC (marker of thymus output) in peripheral blood mononuclear cells (PBMC). Timepoint: Before hematopoietic stem cell transplantation begging and 30, 90, 180 days after transplantation. Method of measurement: In DNA extracted from peripheral blood mononuclear cells using Real-Time-PCR.	—

Measure

Time frame

Number of Recent Thymic Emigrant T-cells in peripheral blood mononuclear cells (PBMC). Timepoint: Before hematopoietic stem cell transplantation begging and 30, 90, 180 days after transplantation. Method of measurement: Using flow cytometry technique and specific RET T cells markers.;Determination of copy number of TREC (marker of thymus output) in peripheral blood mononuclear cells (PBMC). Timepoint: Before hematopoietic stem cell transplantation begging and 30, 90, 180 days after transplantation. Method of measurement: In DNA extracted from peripheral blood mononuclear cells using Real-Time-PCR.

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Secondary

Measure	Time frame
Naive T cells number in the peripheral blood mononuclear cell population (PBMC). Timepoint: Before the hematopoietic stem cell transplantation process and 30, 90 and 180 days after transplantation. Method of measurement: Using flow cytometry techniques and T cells specific markers.;Memory T cells number in the peripheral blood mononuclear cell population (PBMC). Timepoint: Before the hematopoietic stem cell transplantation process and 30, 90 and 180 days after transplantation. Method of measurement: Using flow cytometry techniques and T cells specific markers.	—

Measure

Time frame

Naive T cells number in the peripheral blood mononuclear cell population (PBMC). Timepoint: Before the hematopoietic stem cell transplantation process and 30, 90 and 180 days after transplantation. Method of measurement: Using flow cytometry techniques and T cells specific markers.;Memory T cells number in the peripheral blood mononuclear cell population (PBMC). Timepoint: Before the hematopoietic stem cell transplantation process and 30, 90 and 180 days after transplantation. Method of measurement: Using flow cytometry techniques and T cells specific markers.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad zavaran Hosseini

Tarbiat Modares University

zavarana@modares.ac.ir+98 21 8288 3090

Outcome results

None listed

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