Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: Vitamin-D3-Cholecalciferol (60,000 I.U.): Vitamin-D3-Cholecalciferol (60,000 I.U.) or placebo will be given once weekly for 8 weeks
Intervention2: Imatinib 400 mg once daily to continu
Sponsors
Arkapal Bandyopadhyay
Eligibility
Inclusion criteria
Inclusion criteria: 1. All treatment naïve patients with chronic myeloid leukaemia (chronic phase) 2. Age >12 years 3. Patients willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with de novo accelerated phase or blast phase CML 2. Patients who have already started on any tyrosine kinase inhibitor (TKI) treatment prior to randomization 3. Pregnant & lactating females 4. Patient with baseline serum calcium >10.5 mg/dl 5. Patient with baseline serum creatinine >2 mg/dl 6. Patients who take vitamin-D3 replacement therapy for malabsorption, renal osteodystrophy, osteoporosis, or psoriasis 7. Patients with a known history of renal calculi or any known renal complication. 8. Patients with deranged liver function test
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the effect of Vitamin-D as an add on in complete hematologic response (CHR) 2. To correlate the levels of 25(OH)2D3 levels with treatment response 3. To explore the safety of Vitamin-D supplementation in CML patients on imatinib Timepoint: 3 months from the start of treatment | — |
Primary
| Measure | Time frame |
|---|---|
| To compare the early molecular response rates at 3 months of imatinib therapy with & without vitamin D3 supplementation in patients of newly diagnosed CML chronic phase Timepoint: Early molecular response at 3 months | — |
Countries
India
Contacts
Public ContactArkapal Bandyopadhyay
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed