Calcium Deficiency, Infant, Very Low Birth Weight, Vitamin D Deficiency
Conditions
Keywords
vitamin D, preterm infants, calcium, bone, parathyroid hormone
Brief summary
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.
Interventions
DIETARY_SUPPLEMENT400 IU Cholecalciferol- Vitamin D Daily
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.
Sponsors
National Center for Research Resources (NCRR)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
No
Inclusion criteria
* Any infant born at the Medical University of South Carolina \<34 weeks gestation * Less that 1500g at birth * AGA * Must be African American or Caucasian * Each infant born of twin and triplet pregnancies will be eligible
Exclusion criteria
* Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion * Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA) * Maternal uncontrolled thyroid disease * Maternal Parathyroid disease * Infants of races other than African American or Caucasian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum inflammatory cytokine concentrations | At birth (day 1) | — |
| Parathyroid hormone concentration | At term age (expected 2-4 months) | — |
| Serum 25 hydroxyvitamin D status | At term age (expected 2-4 months) | — |
| Bone Health | At term age (expected 2-4 months) | 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. |
| Intestinal Calcium Absorption | When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth parameters | At term age (expected 2-4 months) | — |
| Vitamin D Dose Safety as Measured by Urinary Calcium Excretion | At term age (expected 2-4 months) | — |
| Phosphorus Homeostasis | At term age (expected 2-4 months) | Measurement of serum and urine phosphorus concentrations |
Countries
United States
Outcome results
None listed