This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Infants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached.
Medical University of South Carolina
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Intestinal Calcium Absorption
Time frame: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth
Parathyroid hormone concentration
Time frame: At term age (expected 2-4 months)
Serum 25 hydroxyvitamin D status
Time frame: At term age (expected 2-4 months)
Bone Health
Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age.
Time frame: At term age (expected 2-4 months)
Serum inflammatory cytokine concentrations
Time frame: At birth (day 1)
Phosphorus Homeostasis
Measurement of serum and urine phosphorus concentrations
Time frame: At term age (expected 2-4 months)
Growth parameters
Time frame: At term age (expected 2-4 months)
Vitamin D Dose Safety as Measured by Urinary Calcium Excretion
Time frame: At term age (expected 2-4 months)
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