Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A11CA01) retinol (vit A)
retinol (vit A)

Medical condition to be studied

Measles
Population studied

Age groups

Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)

Estimated number of subjects

108
Study design details

Main study objective

Test the efficacy of vitamin A in children hospitalized for measles in a high-income setting.

Outcomes

The duration of fever in patients receiving or not vitamin A, was considered as primary outcomes. The length of hospitalization, the incidence of complications, the need of antibiotic treatment, the highest temperature recorded during infection and side effects attributable to vitamin A were considered as secondary outcomes.

Data analysis plan

Vitamin A may reduce the duration of fever by 1.5 days and the length of hospital stay by more than 2 days. Considering those effects as clinically relevant, and assuming an alpha error of 5% with a sampling ratio of 1:2, we initially estimated a study power higher than 80% with the enrollment of 116 children (39 receiving vitamin A supplementation and 77 receiving standard care). However, since May 2019, the number of measles cases significantly dropped in Italy and no other children were hospitalized in the Pediatric Infectious Diseases Unit. We have been able to record data of 36 children receiving vitamin A. Seventy-two children admitted for measles in the same unit and receiving only standard care, due to the vitamin A shortage, were matched for age, gender, season of enrollment (winter season from October 1st to March 31st or summer season from April 1st to September 30th) and presence of underlying chronic conditions, resulting in a study power slightly below 80%.