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
39 participants
INTERVENTIONAL
2013-01-31
2016-07-30
Brief Summary
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Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Investigational Nutrition
Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Investigational Nutrition group will receive vitamin D drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.
Vitamin D
Routine Nutrition
Starting between post menstrual age (PMA) 34 0/7 to 38 6/7 weeks, infants in the Routine Nutrition group will receive placebo drops that are added to transitional formula daily through hospital discharge and at home until the outpatient follow-up visit at 52 weeks PMA.
Placebo
Interventions
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Vitamin D
Placebo
Eligibility Criteria
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Inclusion Criteria
* Currently 34 0/7 to 38 6/7 weeks post-menstrual age at time of consent.
* Born at Texas Children's (including Pavilion for Women) or Methodist campus hospitals or transferred within 48 hours of birth.
* Care expected to be provided at one of these institutions until discharge home.
* Any initial feeding will be permitted, but expected to transition to primarily (80% of feeds or up to 2 breast milk feeds per day) infant formula by 38 6/7 weeks PMA or hospital discharge, whichever comes first.
* Able to tolerate 22 kcal/oz transitional formula and receive a volume of at least 130 mL/kg/day total feeding volume.
* No longer receiving any form of mechanical ventilation or diuretics. Low flow nasal cannula (\< ¼ LPM) will be permitted if it is anticipated this will be discontinued before hospital discharge.
Exclusion Criteria
* Major congenital anomalies, history of proven Stage 2 or above NEC, or severe feeding intolerance.
* Caloric density greater than 22 kcal/oz.
* Higher order multiples (However, twins are acceptable. Twins will be randomized together. Only data from 1 twin picked at random will be used in the final analyses.)
ALL
No
Sponsors
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Mead Johnson Nutrition
INDUSTRY
The Children's Nutrition Research Center
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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Amy Hair
Assistant Professor
Principal Investigators
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Amy h, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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H-31433
Identifier Type: -
Identifier Source: org_study_id
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