Calcitriol in prevention of mucositis in patients with Fanconi anemia undergoing Hematopoietic Stem Cell Transplantation

Efficacy of calcitriol in prevention of high dose chemotherapy induced mucositis in patients with Fanconi anemia undergoing Hematopoietic Stem Cell Transplantation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201307141030N15

Enrollment

Registered

2013-07-16

Start date

2013-08-01

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

Fanconi Anemia. Constitutional aplastic anaemia

Interventions

Intervention 1: Calcitriol 0.25 mcg/d. Intervention 2: Placebo.

Treatment - Drugs

Placebo

Calcitriol 0.25 mcg/d

Eligibility

Sex/Gender

All

Age

1 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Patients with Fanconi anemia 2- Age limit 1-15 years 3- Patient’s Parents or guardians’ informed consent Exclusion criteria: 1- 25-OH vitamin D >100 ng/ml 2- Ca>10 mg/dl 3- P>4.6 mg/dl 4- give vitamin D supplementation within past three months

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of mucositis. Timepoint: From the first day of chemotherapy for 14 days and 3 times weekly thereafter for up to 28 days from beginning of therapy. Method of measurement: Physical Examination.	—

Secondary

Measure	Time frame
Duration of mucositis. Timepoint: From the first day of chemotherapy for 14 days and 3 times weekly thereafter for up to 28 days from beginning of therapy. Method of measurement: Physical Examination.;Incidence of GVHD. Timepoint: From the first day of transplantation until the day of discharge. Method of measurement: Physical Examination.;Severity of GVHD. Timepoint: From the first day of transplantation until the day of discharge. Method of measurement: Clinical examinations and Laboratory data.;Incidence of Infection. Timepoint: From the first day of transplantation until the day of discharge. Method of measurement: Clinical examinations and Laboratory data.;Duration of infection. Timepoint: From the first day of transplantation until the day of discharge. Method of measurement: Clinical examinations and Laboratory data.	—

Measure

Time frame

Duration of mucositis. Timepoint: From the first day of chemotherapy for 14 days and 3 times weekly thereafter for up to 28 days from beginning of therapy. Method of measurement: Physical Examination.;Incidence of GVHD. Timepoint: From the first day of transplantation until the day of discharge. Method of measurement: Physical Examination.;Severity of GVHD. Timepoint: From the first day of transplantation until the day of discharge. Method of measurement: Clinical examinations and Laboratory data.;Incidence of Infection. Timepoint: From the first day of transplantation until the day of discharge. Method of measurement: Clinical examinations and Laboratory data.;Duration of infection. Timepoint: From the first day of transplantation until the day of discharge. Method of measurement: Clinical examinations and Laboratory data.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMona Sherafatmand

Hematology Oncology and SCT Research Center

horcbmt@tums.ac.ir+98 21 8490 2635

Outcome results

None listed

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