Effect of Vitamin D in Diets of Preterm Infants
|ClinicalTrials.gov Identifier: NCT01698840|
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : February 2, 2018
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|
|Premature Infants||Dietary Supplement: Vitamin D Dietary Supplement: Placebo|
|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|
|Primary Completion Date :||July 2016|
|Study Completion Date :||January 2017|
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 ]
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|