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 : May 18, 2020
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 2021|
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 ]
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|