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

Vitamin D Deficiency Clinical Trial

Official title:

Identifying Vit D Deficiency in VLBW Infants Part 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363167
• Other study ID #: HR# 17217
• Secondary ID: K23RR021891
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: November 21, 2014
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2014
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Calcium Deficiency
• Infant, Very Low Birth Weight
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal Calcium Absorption		When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth	No
Primary	Parathyroid hormone concentration		At term age (expected 2-4 months)	No
Primary	Serum 25 hydroxyvitamin D status		At term age (expected 2-4 months)	Yes
Primary	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)	No
Primary	Serum inflammatory cytokine concentrations		At birth (day 1)	No
Secondary	Phosphorus Homeostasis	Measurement of serum and urine phosphorus concentrations	At term age (expected 2-4 months)	No
Secondary	Growth parameters		At term age (expected 2-4 months)	No
Secondary	Vitamin D Dose Safety as Measured by Urinary Calcium Excretion		At term age (expected 2-4 months)	Yes