MedTrace Logo

Effect of Vitamin D in Diets of Preterm Infants

NCT01698840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-01-29

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Mead Johnson Nutrition

    collaborator INDUSTRY

  • The Children's Nutrition Research Center

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Amy h, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-07-30
Completion
2016-07-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01698840 on ClinicalTrials.gov