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

Identifying Vit D Deficiency in VLBW Infants Part 2

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 Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Infant, Very Low Birth Weight; Calcium Deficiency
• Intervention / Treatment: Dietary supplement: 400 IU Cholecalciferol- Vitamin D Daily

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29425-8750
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 400 IU Cholecalciferol - Vitamin D	Dietary supplement: 400 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.
Placebo Comparator: Placebo; Placebo contains Fractionated Coconut Oil	Dietary supplement: 400 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.

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)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Sarah N. Taylor, M.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 18, 2011
• First Submitted That Met QC Criteria: May 31, 2011
• First Posted (Estimate): June 1, 2011

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 21, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: preterm infants; bone; vitamin D; parathyroid hormone; calcium
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Birth Weight; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: HR# 17217; K23RR021891 (U.S. NIH Grant/Contract)