Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
Identifying Vit D Deficiency in VLBW Infants Part 2
2 other identifiers
interventional
68
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedNovember 24, 2014
November 1, 2014
2 years
April 18, 2011
November 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
Phosphorus Homeostasis
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)
Study Arms (2)
400 IU Cholecalciferol - Vitamin D
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORPlacebo contains Fractionated Coconut Oil
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical University of South Carolina
Charleston, South Carolina, 29425-8750, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah N. Taylor, M.D.
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics, Medical University of SC
Study Record Dates
First Submitted
April 18, 2011
First Posted
June 1, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
November 24, 2014
Record last verified: 2014-11