Effect of Vitamin D in Diets of Preterm Infants

This study is currently recruiting participants.
Verified May 2013 by Baylor College of Medicine
Sponsor:
Collaborators:
USDA Beltsville Human Nutrition Research Center
Mead Johnson Nutrition
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01698840
First received: September 24, 2012
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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 Intervention
Premature Infants
Dietary Supplement: Vitamin D

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698840

Contacts
Contact: Keli Hawthorne, MS, RD, LD 713-798-7085 kelih@bcm.edu

Locations
United States, Texas
Baylor College of Medicine / Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Keli M Hawthorne, MS, RD    713-798-7085    kelih@bcm.edu   
Principal Investigator: Steve Abrams, MD         
Sub-Investigator: Keli M Hawthorne, MS, RD         
Sub-Investigator: Amy Hair, MD         
Sub-Investigator: Lori Pandya, MD         
Sub-Investigator: Adel Elhennawy, MD         
Sponsors and Collaborators
Baylor College of Medicine
USDA Beltsville Human Nutrition Research Center
Mead Johnson Nutrition
Investigators
Principal Investigator: Steven Abrams, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01698840     History of Changes
Other Study ID Numbers: H-31433
Study First Received: September 24, 2012
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Vitamin D
Transitional Formula

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014