Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2

Study Overview
=================
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.

Official Title
-----------------
Identifying Vit D Deficiency in VLBW Infants Part 2

Conditions
-----------------
Infant, Very Low Birth Weight, Calcium Deficiency, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 400 IU Cholecalciferol - Vitamin D<br> | Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo contains Fractionated Coconut Oil | Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Calcium Absorption |  | When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth | 
| Parathyroid hormone concentration |  | At term age (expected 2-4 months) | 
| Serum 25 hydroxyvitamin D status |  | 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. | At term age (expected 2-4 months) | 
| Serum inflammatory cytokine concentrations |  | At birth (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phosphorus Homeostasis | Measurement of serum and urine phosphorus concentrations | At term age (expected 2-4 months) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, preterm infants, calcium, bone, parathyroid hormone