Nutritional Outcomes After Vitamin A Supplementation in Subjects With SCD

Completed · Not applicable

Conditions studied: Sickle Cell Anemia in Children, Vitamin A Deficiency in Children

In brief

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.

Key facts

Study ID

NCT03632876

Run by

Children's Hospital of Philadelphia

People needed

42

Starts

2015-10-02

Expected to finish

2016-09-30

Last updated by the study team

2018-08-16

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Sickle cell disease, SS genotype (subjects with sickle cell disease only)
• Usual state of good health (no hospitalizations, emergency room visits, or unscheduled acute illness clinic visits for two weeks prior to screening)
• Commitment to a 119-day study (subjects with sickle cell disease only), or a 4-day study (healthy volunteers only)

You may not qualify if…

• Hydroxyurea initiated within the previous 6 weeks (subjects with sickle cell disease only)
• History of stroke (subjects with sickle cell disease only)
• Other chronic conditions that may affect growth, dietary intake or nutritional status
• Retinoic acid (topical or oral), weight loss medication and/or lipid lowering medications
• Subjects with a BMI greater than 98th percentile for age and sex
• Pregnant or lactating females (subjects who become pregnant during the course of the study will not continue participation)
• Liver function tests >4 x upper limit of reference range
• Participation in another study with impact on vitamin A status (subjects with sickle cell disease only)
• Use of multi-vitamin or commercial nutritional supplements containing vitamin A (those who are willing to discontinue these supplements, with the approval of the medical care team, will be eligible for the study after a 1 month washout period. Subjects taking nutritional products without vitamin A will be eligible)
• Inability to swallow pills (subjects with sickle cell disease only)

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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