Vitamin D Supplementation for Extremely Preterm Infants
NCT ID: NCT01600430
Last Updated: 2017-02-10
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
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2012-06-30
2016-12-31
Brief Summary
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Detailed Description
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Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.
Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D \[25(OH)D\]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.
Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations \>60ng/mL (\>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (\<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.
All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
Cholecalciferol
200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days
Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
Placebo
Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days
Oral Vitamin D--800 IU/day
Cholecalciferol 800 IU given orally once per day
Cholecalciferol
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days
Interventions
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Cholecalciferol
200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days
Cholecalciferol
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days
Placebo
Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Moribund infant with low likelihood of survival, in opinion of the clinical team
1 Minute
7 Days
ALL
No
Sponsors
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Children's Health System, Alabama
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Namasivayam Ambalavanan
Professor of Pediatrics
Principal Investigators
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Namasivayam Ambalavanan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Ariel A. Salas, MD
Role: STUDY_DIRECTOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Aristizabal N, Holder MP, Durham L, Ashraf AP, Taylor S, Salas AA. Safety and Efficacy of Early Vitamin D Supplementation in Critically Ill Extremely Preterm Infants: An Ancillary Study of a Randomized Trial. J Acad Nutr Diet. 2023 Jan;123(1):87-94. doi: 10.1016/j.jand.2022.06.012. Epub 2022 Jun 18.
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.
Other Identifiers
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UAB Neo 006
Identifier Type: -
Identifier Source: org_study_id
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