A clinical trial to study the effect of vitamin A supplementation in babies with birth weight from 750 grams to 1250 grams

A randomized controlled trial of vitamin A supplementation in babies with birth weight from 750 to 1250 grams

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000010

Enrollment

120

Registered

2009-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: vitamin A: 5,000 IU (0.125ml)IM on alternate days till establishment of adequate enteral feeds followed by oral vitamin A 10,000 IU (1 ml) once daily for a total duration of 28 days Con

Eligibility

Inclusion criteria

Inclusion criteria: All infants admitted to the neonatal intensive care unit with birth weight between 750 and 1250 grams and between 24 to 96 hours of life

Exclusion criteria

Exclusion criteria: lethal congenital malformations, terminal illness characterized by shock or bradycardia for more than 2 hours, refusal of consent

Design outcomes

Primary

Measure	Time frame
proportion of infants with vitamin A deficiency (plasma retinol <200 mcg/L)Timepoint: study day 28	—

Secondary

Measure	Time frame
Proportion of infants with plasma retinol <200 mcg/L at study day 14 Proportion of infants with relative Retinol binding protein response >10% Duration of oxygen administration Duration of ventilation Rates of Bronchopulmonary dysplasia Rates of Sepsis, Intraventricular hemorrhage MortalityTimepoint: study day 28;rates of pneumonia and retinopathy of prematurityTimepoint: study day 28	—

Countries

India

Contacts

Public ContactGiridhar S

giridharsethu@hotmail.com9915287228

Outcome results