Effect of Vitamin D in Diets of Preterm Infants
This study is not yet open for participant recruitment.
Verified October 2012 by Baylor College of Medicine
Sponsor:
Baylor College of Medicine
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: October 1, 2012
Last verified: October 2012
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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 | |
| Houston, Texas, United States, 77030 | |
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: | October 1, 2012 |
| 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 May 16, 2013