NCT03632876

Nutritional Outcomes After Vitamin A Supplementation in Subjects With SCD

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 9 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Sickle Cell Anemia in Children
• Vitamin A Deficiency in Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	retinyl palmitate	The intervention is a daily vitamin A supplement.

Timeline

• Start date: 2015-10-02
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2018-08-16
• Last updated: 2018-08-16

Locations

1 site across 1 country: United States