Effect of Vitamin D in Diets of Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 6, 2014
Last verified: June 2014
  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 2015
Estimated Primary Completion Date: July 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 6, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 29, 2014