A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCT

PHASE4CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

November 1, 2017

Primary Completion Date

July 1, 2019

Study Completion Date

July 1, 2019

Conditions
Vitamin D DeficiencyStem Cell Transplant ComplicationsPediatric CancerBlood DisorderPediatric Acute Myeloid LeukemiaPediatric Acute Lymphoid LeukemiaMyelodysplastic SyndromesSickle Cell Anemia in ChildrenAplastic AnemiaThalassemia in Children
Interventions
DIETARY_SUPPLEMENT

Vitamin D3

The single, oral dose of vitamin D3 is based on patient's age and baseline 25-hydroxy-vitamin D level. Dosing is as follows: (1) For children under 3 years of age. 200000IU for those deficient, 150000IU for those insufficient, and 100000IU for those sufficient; (2) For children 3-12 years of age, 400000IU for those deficient, 350000IU for those insufficient, and 200000IU for those sufficient; (3) For children greater than 12 years of age, 600000IU for those deficient, 500000IU for those insufficient, and 300000IU for those sufficient. This is a single, one time oral dose given prior to the start of transplant.

DIETARY_SUPPLEMENT

Standard Vitamin D3 Supplementation

"Those who have sufficient vitamin D will be supplemented with 400-600IU/day of Vitamin D3 orally.~Those who have insufficient or are deficient in vitamin D will be supplemented with 50,000IU/week of Vitamin D3 orally."

Trial Locations (1)

85016

Phoenix Children's Hospital, Phoenix

All Listed Sponsors
lead

Phoenix Children's Hospital

OTHER

NCT03176849 - A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCT | Biotech Hunter | Biotech Hunter