Effect of Vitamin D in Diets of Preterm Infants
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|ClinicalTrials.gov Identifier: NCT01698840|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2012
Last Update Posted : March 29, 2023
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Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation at birth. However, few data are available related to follow-up of infants receiving these formulas who were 28-34 weeks gestation at birth.
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).
|Condition or disease||Intervention/treatment||Phase|
|Premature Infants||Dietary Supplement: Vitamin D Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||An Evaluation of the Effects of Two Levels of Vitamin D in Infants Fed Preterm or Transitional Formula on Serum 25-Hydroxyvitamin D and Bone Status in Preterm Infants: A Double-Blind, Randomized Controlled Trial|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||December 2023|
Experimental: 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.
Dietary Supplement: Vitamin D
Placebo Comparator: 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.
Dietary Supplement: Placebo
- Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age [ Time Frame: Last 7 days of hospitalization and at 52 weeks post-menstrual age (PMA) ]
- Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age [ Time Frame: Last 7 days of hospitalization and at 52 weeks PMA ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Born at 28 0/7 to 34 6/7 weeks PMA and 1000-2250 g birth weight.
- 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.
- Bronchopulmonary dysplasia (BPD) requiring daily use of diuretics beyond 38 6/7 weeks PMA (or hospital discharge, whichever comes first) and > 22 kcal/oz concentration formula beyond 38 6/7 weeks PMA.
- 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.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698840
|United States, Texas|
|Baylor College of Medicine / Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amy h, MD||Baylor College of Medicine|
|Responsible Party:||Amy Hair, Assistant Professor, Baylor College of Medicine|
|Other Study ID Numbers:||
|First Posted:||October 3, 2012 Key Record Dates|
|Last Update Posted:||March 29, 2023|
|Last Verified:||March 2023|
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