Effect of Vitamin D in Diets of Preterm Infants

Premature Infants Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01698840
• Other study ID #: H-31433
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: December 2024
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Premature Infants

Intervention

Dietary Supplement:
• Vitamin D

• Placebo

Locations

Country	Name	City	State
United States	Baylor College of Medicine / Texas Children's Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	Mead Johnson Nutrition, The Children's Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Serum 25-hydroxyvitamin D (25-OHD) level at 52 weeks post-menstrual age		Last 7 days of hospitalization and at 52 weeks post-menstrual age (PMA)
Secondary	Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age		Last 7 days of hospitalization and at 52 weeks PMA