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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
400 IU Cholecalciferol- Vitamin D Daily
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Very Low Birth Weight focused on measuring vitamin D, preterm infants, calcium, bone, parathyroid hormone

Eligibility Criteria

1 Day - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

400 IU Cholecalciferol - Vitamin D

Placebo

Arm Description

Placebo contains Fractionated Coconut Oil

Outcomes

Primary Outcome Measures

Intestinal Calcium Absorption
Parathyroid hormone concentration
Serum 25 hydroxyvitamin D status
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.
Serum inflammatory cytokine concentrations

Secondary Outcome Measures

Phosphorus Homeostasis
Measurement of serum and urine phosphorus concentrations
Growth parameters
Vitamin D Dose Safety as Measured by Urinary Calcium Excretion

Full Information

First Posted
April 18, 2011
Last Updated
November 21, 2014
Sponsor
Medical University of South Carolina
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT01363167
Brief Title
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
Official Title
Identifying Vit D Deficiency in VLBW Infants Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Very Low Birth Weight, Calcium Deficiency, Vitamin D Deficiency
Keywords
vitamin D, preterm infants, calcium, bone, parathyroid hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400 IU Cholecalciferol - Vitamin D
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo contains Fractionated Coconut Oil
Intervention Type
Dietary Supplement
Intervention Name(s)
400 IU Cholecalciferol- Vitamin D Daily
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intestinal Calcium Absorption
Time Frame
When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth
Title
Parathyroid hormone concentration
Time Frame
At term age (expected 2-4 months)
Title
Serum 25 hydroxyvitamin D status
Time Frame
At term age (expected 2-4 months)
Title
Bone Health
Description
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)
Title
Serum inflammatory cytokine concentrations
Time Frame
At birth (day 1)
Secondary Outcome Measure Information:
Title
Phosphorus Homeostasis
Description
Measurement of serum and urine phosphorus concentrations
Time Frame
At term age (expected 2-4 months)
Title
Growth parameters
Time Frame
At term age (expected 2-4 months)
Title
Vitamin D Dose Safety as Measured by Urinary Calcium Excretion
Time Frame
At term age (expected 2-4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah N. Taylor, M.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8750
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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

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