Effect of Vitamin D in Diets of Preterm Infants
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- 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) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698840
|Contact: Amy B Hair, MDfirstname.lastname@example.org|
|United States, Texas|
|Baylor College of Medicine / Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Amy B Hair, MD 832-826-3719 email@example.com|
|Contact: Andrea R O'Donnell, RD firstname.lastname@example.org|
|Principal Investigator: Amy Hair, MD|
|Sub-Investigator: Andrea O'Donnell, RD|
|Principal Investigator:||Amy h, MD||Baylor College of Medicine|