Vitamin D Supplementation for Extremely Preterm Infants

The University of Alabama at Birmingham

Status and phase: Completed; Phase 3; Phase 2

Conditions: Vitamin D Deficiency; Preterm Infants; Bronchopulmonary Dysplasia

Treatments: Dietary Supplement: Cholecalciferol; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01600430

UAB Neo 006

Details and patient eligibility

About

The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.

Full description

After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.

Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.

Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.

Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.

All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.

Enrollment: 100 patients

Sex: All

Ages: 1 minute to 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks

Exclusion criteria

• Major congenital/chromosomal anomalies
• Moribund infant with low likelihood of survival, in opinion of the clinical team

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups, including a placebo group

Oral Vitamin D--200 IU/day

Active Comparator group

Description:

Cholecalciferol 200 IU given orally once per day

Treatment:

Dietary Supplement: Cholecalciferol

Dietary Supplement: Cholecalciferol

Placebo

Placebo Comparator group

Description:

Identical-appearing treatment that does not contain the test drug given orally four times per day.

Treatment:

Dietary Supplement: Placebo

Oral Vitamin D--800 IU/day

Active Comparator group

Description:

Cholecalciferol 800 IU given orally once per day

Treatment:

Dietary Supplement: Cholecalciferol

Dietary Supplement: Cholecalciferol