Effects of calcitriol on the complications of hematopoietic stem cell transplantation

The effects of calcitriol on the incidence rate and severity of oral mucositis in patients undergoing 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

IRCT2016052727435N2

Enrollment

Registered

2016-07-08

Start date

2016-04-20

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 lymphoma. Condition 2: Non-Hodgkin lymphoma. Condition 3: Multiple myeloma. 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 14 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 14 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

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 18 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
Incidence rate of oral mucositis. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation. Method of measurement: visiting the oral cavitiy by clinical pharmacist.;Severity of oral mucositis. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation or up to day of healing of oral mucositis. Method of measurement: scoring upon WHO grading system for severity of oral mucositis.;Duration of oral mucositis condition. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation or up to day of healing of oral mucositis. Method of measurement: Daily visiting of the oral cavitiy by clinical pharmacist.	—

Measure

Time frame

Incidence rate of oral mucositis. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation. Method of measurement: visiting the oral cavitiy by clinical pharmacist.;Severity of oral mucositis. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation or up to day of healing of oral mucositis. Method of measurement: scoring upon WHO grading system for severity of oral mucositis.;Duration of oral mucositis condition. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation or up to day of healing of oral mucositis. Method of measurement: Daily visiting of the oral cavitiy by clinical pharmacist.

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Secondary

Measure	Time frame
Serum level of calcitriol. Timepoint: Before the conditioning regimen before transplantation and on day 14 after transplantation. Method of measurement: Laboratory kit of 1,25-(OH)2-D.;Serum level of vitamin D. Timepoint: Before the conditioning regimen before transplantation. Method of measurement: Laboratory kit of 25-OH-D.;Incidence rate of fever. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Lenght of fever. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Number od days receiveing total parentral nutrition. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Number of days receiveing Analgesic drugs. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Hypercalcemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum calcium by laboratory.;Hypocalcemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum calcium by laboratory.;Hyperphosphatemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum phosphorus by laboratory.;Hypophosphatemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum phosphorus by laboratory.;Length of hospital stay. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Number od days receiveing antibiotics. Timepoint: On discharge. Method of measurement: Patient's hospital file.	—

Measure

Time frame

Serum level of calcitriol. Timepoint: Before the conditioning regimen before transplantation and on day 14 after transplantation. Method of measurement: Laboratory kit of 1,25-(OH)2-D.;Serum level of vitamin D. Timepoint: Before the conditioning regimen before transplantation. Method of measurement: Laboratory kit of 25-OH-D.;Incidence rate of fever. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Lenght of fever. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Number od days receiveing total parentral nutrition. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Number of days receiveing Analgesic drugs. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Hypercalcemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum calcium by laboratory.;Hypocalcemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum calcium by laboratory.;Hyperphosphatemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum phosphorus by laboratory.;Hypophosphatemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum phosphorus by laboratory.;Length of hospital stay. Timepoint: On discharge. Method of measurement: Patient's hospital file.;Number od days receiveing antibiotics. Timepoint: On discharge. Method of measurement: Patient's hospital file.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlborz Soroush

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

a_soroush@razi.tums.ac.ir00

Outcome results

None listed

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