Effects of calcitriol on the complications of hematopoietic stem cell transplantation

Effects of oral calcitriol versus placebo on hematologic and immunologic reconstitution after autologous hematopoietic stem cell transplantation: a double-blind, randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015120816837N2

Enrollment

Registered

2016-05-26

Start date

2015-12-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: Hodgkin’s lymphoma. Condition 2: Non-Hodgkin’s lymphoma. Condition 3: Multiple myelomas. Hodgkin lymphoma Follicular lymphoma, Non-follicular lymphoma, Mature T/NK-cell lymphomas, Other and unspecified types of non-Hodgkin lymphoma Multiple myeloma and malignant plasma cell neoplasms

Interventions

Intervention 1: Oral calcitriol 0.25 mcg pearls will be administered three times daily after receiving the conditioning regimen up to day +30 after transplantation. Intervention 2: Oral placebo pearls

Treatment - Drugs

Placebo

Oral calcitriol 0.25 mcg pearls will be administered three times daily after receiving the conditioning regimen up to day +30 after transplantation.

Oral placebo pearls similarly look like the calcitriol pearls but without the active pharmaceutical ingredient will be administered three times daily after receiving the conditioning regimen up to day

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 16 and 65 years; cases of Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, or multiple myelomas; candidates for autologous peripheral blood hematopoietic stem cell transplantation. Exclusion criteria: baseline serum calcium >10.5mg/dL; baseline serum phosphorous >4.5mg/dL;history of renal stones in the past 5 years; baseline serum creatinine >1.3mg/dL; alkaline phosphatase x4 the upper limit of normal or higher; alanine transaminase >60U/L; total bilirubin >2mg/dL; sensitivity to calcitriol; disability for oral intake.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Time to absolute neutrophil engraftment. Timepoint: Every day after transplantation up to the day of absolute neutrophil engraftment. Method of measurement: Compelete Blood Count and Differential Test.;Time to platelet engraftment. Timepoint: Every day after transplantation up to the day of platelet engraftment. Method of measurement: Complete Blood Count Test.;Time to absolute lymphocyte recovery. Timepoint: Every day after transplantation up to the day of absolute lymphocyte recovery. Method of measurement: Compelete Blood Count and Differential Test.	—

Measure

Time frame

Time to absolute neutrophil engraftment. Timepoint: Every day after transplantation up to the day of absolute neutrophil engraftment. Method of measurement: Compelete Blood Count and Differential Test.;Time to platelet engraftment. Timepoint: Every day after transplantation up to the day of platelet engraftment. Method of measurement: Complete Blood Count Test.;Time to absolute lymphocyte recovery. Timepoint: Every day after transplantation up to the day of absolute lymphocyte recovery. Method of measurement: Compelete Blood Count and Differential Test.

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Secondary

Measure	Time frame
Absolute neutrophil count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Absolute neutrophil count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Platelet count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test.;Platelet count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count Test.;Absolute lymphocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Absolute lymphocyte count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Hemoglobin concentration on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test.;Hemoglobin concentration on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count Test.;Absolute monocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Absolute monocyte count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Time to leukocyte engraftment. Timepoint: Every day after transplantation up to the day of leukocyte engraftment. Method of measurement: Complete Blood Count Test.;Leukocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test.;Leukocyte co	—

Measure

Time frame

Absolute neutrophil count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Absolute neutrophil count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Platelet count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test.;Platelet count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count Test.;Absolute lymphocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Absolute lymphocyte count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Hemoglobin concentration on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test.;Hemoglobin concentration on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count Test.;Absolute monocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Absolute monocyte count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test.;Time to leukocyte engraftment. Timepoint: Every day after transplantation up to the day of leukocyte engraftment. Method of measurement: Complete Blood Count Test.;Leukocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test.;Leukocyte co

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Kosar Raoufinejad

Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran,

k-raoufinejad@razi.tums.ac.ir+98 21 6695 4709

Outcome results

None listed

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