Nutritional Outcomes After Vitamin A Supplementation in Subjects With SCD

Sickle Cell Anemia in Children Clinical Trial

Official title: Vitamin A in Sickle Cell Disease: Improving Sub-optimal Status With Supplementation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Night Blindness
• Sickle Cell Anemia in Children
• Vitamin A Deficiency
• Vitamin A Deficiency in Children

• NCT number: NCT03632876
• Study type: Interventional
• Source: Children's Hospital of Philadelphia
• Status: Completed
• Phase: N/A
• Start date: October 2, 2015
• Completion date: September 30, 2016