Nutritional Outcomes After Vitamin A Supplementation in Subjects With SCD

Clinical Trial
Study Details
Enrollment
42
Interventions
Description

The intervention is a daily vitamin A supplement.

Name
retinyl palmitate
Type
Dietary Supplement
Phase
N/A
Status
COMPLETED
Study ID #
NCT03632876
Study Type
Interventional
Summary

This study establishes the safety and efficacy of vit A supplementation doses (3000 and 6000 IU/d) over 8 weeks in children with SCD-SS, ages 9 and older and test the impact of vit A supplementation on key functional and clinical outcomes. Additionally, vitamin A status is assessed in healthy children ages 9 and older to compare to subjects with SCD-SS.

Study Overview
Description

Suboptimal vitamin A (vit A) status is prevalent in children with type SS sickle cell disease (SCD-SS) and associated with hospitalizations and poor growth and hematological status. Preliminary data in children with SCD-SS show that vit A supplementation at the dose recommended for healthy children failed to improve vit A status, resulting in no change in hospitalizations, growth or dark adaptation. This indicates an increased vit A requirement most likely due to chronic inflammation, low vit A intake and possible stool or urine loss. The dose of vit A needed to optimize vit A status in subjects with SCD-SS is unknown.

Contacts and Locations
Locations
Facility

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19146
United States

GeoPoint
39.95238, -75.16362