Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm

The University of Alabama at Birmingham

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Prematurity; Extreme

Treatments: Dietary Supplement: Vitamin D supplementation; Other: No additional vitamin D supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05615311

300010307

Details and patient eligibility

About

This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.

Enrollment: 126 estimated patients

Sex: All

Ages: 1 to 4 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age of 28 weeks or less

Exclusion criteria

• Major congenital anomalies and infants
• Terminal illness in whom decisions to withhold or limit life support have been made

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Vitamin D group

Experimental group

Treatment:

Dietary Supplement: Vitamin D supplementation

Control group

Placebo Comparator group

Treatment:

Other: No additional vitamin D supplementation