Calcitriol in prevention of mucositis in patients with Fanconi anemia undergoing Hematopoietic Stem Cell Transplantatio
Phase 2
- Conditions
- Fanconi Anemia.Constitutional aplastic anaemia
- Registration Number
- IRCT201307141030N15
- Lead Sponsor
- Hematology Oncology and SCT Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.