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Clinical Trials/CTRI/2024/05/067371
CTRI/2024/05/067371RecruitingPhase 4

A study to compare changes in serum vitamin b12 levels by oral and parenteral regimens in children with vitamin b12 deficient children

Dr Sampurnanand Medical College1 site in 1 country74 target enrollmentStarted: May 24, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
74
Locations
1
Primary Endpoint
To compare the change in serum vitamin B12 levels after parenteral and oral vitamin B12 supplementation in vitamin B12 deficiency

Study Overview

Brief Summary

This is a prospective randomised study to compare change in serum vitamin b12 levels by oral and parenteral regimen

in children with vitamin b12 deficient anemia

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
6.00 Month(s) to 18.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All children aged 6 months to 18 year, attending OPD or admitted in the indoor wards of the Department of Pediatrics at UMAID or MDM hospital, Jodhpur with the diagnosis of nutritional anemia shall be recruited for study.

Exclusion Criteria

  • Patient with history of vitamin B12 intake in last 3 months and those who had blood tranfusions in last 1 month Proven coeliac disease Proven malabsorption disease Patients not meeting hematological parameters.

Outcomes

Primary Outcomes

To compare the change in serum vitamin B12 levels after parenteral and oral vitamin B12 supplementation in vitamin B12 deficiency

Time Frame: To compare the change in serum vitamin B12 levels after parenteral and oral vitamin B12 supplementation in vitamin B12 deficienc at 4 weeks,8 weeks and 12 weeks

Secondary Outcomes

  • Improvement in hemoglobin level and normalisation of hematological indices,after supplentation with each of the regime(1 YEAR)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

DR ARVIND BISHNOI

DR SAMPURNANAND MEDICAL COLLEGE ,JODHPUR

Study Sites (1)

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