Effect of Vitamin D in Diets of Preterm Infants

NCT01698840 | Completed

• 1 other identifier: H-31433
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Premature Infants

Keywords

Vitamin D; Transitional Formula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline in Alkaline phosphatase activity at 52 weeks post-menstrual age

  Last 7 days of hospitalization and at 52 weeks PMA

Study Arms (2)

Investigational Nutrition

EXPERIMENTAL

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

Routine Nutrition

PLACEBO COMPARATOR

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

Interventions

Vitamin D DIETARY_SUPPLEMENT

Investigational Nutrition

Placebo DIETARY_SUPPLEMENT

Routine Nutrition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Mead Johnson Nutrition: collaborator
• The Children's Nutrition Research Center: collaborator

Study Sites (1)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Amy h, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: October 3, 2012
• Study Start: January 1, 2013
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)