Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
NCT ID: NCT01363167
Last Updated: 2014-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2011-10-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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400 IU Cholecalciferol - Vitamin D
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
Placebo contains Fractionated Coconut Oil
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
1 Day
3 Days
ALL
No
Sponsors
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National Center for Research Resources (NCRR)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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Sarah N Taylor
Assistant Professor of Pediatrics, Medical University of SC
Principal Investigators
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Sarah N. Taylor, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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HR# 17217
Identifier Type: -
Identifier Source: org_study_id