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Neuroprotective Effect of Vitamin B12 and Vitamin B6 Against Vincristine Induced Peripheral Neuropathy

NCT02923388 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2019-11-08

No results posted yet for this study

Summary

This study will be conducted to evaluate the effect of vitamin B12 and vitamin B6 in delaying the onset and reducing the incidence and severity of Vincristine Induced Peripheral Neuropathy (VIPN) in Acute Lymphoblastic Leukemia (ALL) patient.

Conditions

  • Vincristine Induced Peripheral Neuropathy (VIPN)

Interventions

DRUG

Injection Mecobalamin,

Injection Mecobalamin (500mcg) three times a week (day 1, 3 and 5 of vincristine chemotherapy) for 5 weeks.

DRUG

Tablet Pyridoxine hydrochloride

Tab. Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks

DRUG

Intravenous normal saline 1 ml

Normal saline 1 ml three times a week (day 1, 3 and 5 of vincristine chemotherapy) for 5 weeks

DRUG

Placebo pill

Placebo pill orally thrice daily for 5 weeks

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-06-30
Completion
2018-07-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02923388 on ClinicalTrials.gov