Efficacy of calcitriol in prevention of high dose chemotherapy induced mucositis in patients with Fanconi anemia undergoing Hematopoietic Stem Cell Transplantation
This is a randomized double blind placebo controlled trial on 1-15 year old patients with Fanconi anemia undergoing Hematopoietic Stem Cell Transplantation in Shariati hospital, affiliated to Tehran University of Medical Sciences. Patients will randomly receive 0.25 mcg calcitriol or placebo once daily from the first day of chemotherapy for 14 days. Baseline serum calcium, phosphorus and 25-OH vitD levels will be measured. patients will be assessed daily regarding the onset and severity of mucositis from the first day of chemotherapy for 14 days and 3 times weekly thereafter for up to 28 days from beginning of therapy. Serum calcium and phosphorus levels will be measured twice weekly during the period of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307141030N15
Registration date:2013-07-16, 1392/04/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Mahdi Jalili
Name of organization / entity
Hematology-Oncology & SCT Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2662
Email address
m_jalili@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology, Oncology and SCT Research Center
Expected recruitment start date
2013-08-01, 1392/05/10
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of calcitriol in prevention of high dose chemotherapy induced mucositis in patients with Fanconi anemia undergoing Hematopoietic Stem Cell Transplantation
Public title
Calcitriol in prevention of mucositis in patients with Fanconi anemia undergoing Hematopoietic Stem Cell Transplantation
Purpose
Prevention
Inclusion/Exclusion 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
Age
From 1 year old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmaceutical Sciences Research Center
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-02-06, 1390/11/17
Ethics committee reference number
90-11-17:2-15
Health conditions studied
1
Description of health condition studied
Fanconi Anemia
ICD-10 code
D61.0
ICD-10 code description
Constitutional aplastic anaemia
Primary outcomes
1
Description
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 outcomes
1
Description
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
2
Description
Incidence of GVHD
Timepoint
From the first day of transplantation until the day of discharge
Method of measurement
Physical Examination
3
Description
Severity of GVHD
Timepoint
From the first day of transplantation until the day of discharge
Method of measurement
Clinical examinations and Laboratory data
4
Description
Incidence of Infection
Timepoint
From the first day of transplantation until the day of discharge
Method of measurement
Clinical examinations and Laboratory data
5
Description
Duration of infection
Timepoint
From the first day of transplantation until the day of discharge
Method of measurement
Clinical examinations and Laboratory data
Intervention groups
1
Description
Calcitriol 0.25 mcg/d
Category
Treatment - Drugs
2
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology-Oncology and SCT Research Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology Oncology and SCT Research Center
Full name of responsible person
Zohreh Shahabi
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology Oncology and SCT Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hematology Oncology and SCT Research Center
Full name of responsible person
Mona Sherafatmand
Position
ParmD
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
horcbmt@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology Oncology and SCT Research Center
Full name of responsible person
Molok Hajibabaei
Position
Clinical pharmacy /associated prof
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
horcbmt@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hematology-Oncology & SCT Research Center
Full name of responsible person
Mahdi Jalili
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
horcbmt@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)