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Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2

This study is currently recruiting participants.
Verified November 2011 by Medical University of South Carolina
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Sarah N Taylor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01363167
First received: April 18, 2011
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.


Condition Intervention
Infant, Very Low Birth Weight
Calcium Deficiency
Vitamin D Deficiency
 Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Identifying Vit D Deficiency in VLBW Infants Part 2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Intestinal Calcium Absorption [ Time Frame: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth ] [ Designated as safety issue: No ]
  • Parathyroid hormone concentration [ Time Frame: At term age (expected 2-4 months) ] [ Designated as safety issue: No ]
  • Serum 25 hydroxyvitamin D status [ Time Frame: At term age (expected 2-4 months) ] [ Designated as safety issue: Yes ]
  • Bone Health [ Time Frame: At term age (expected 2-4 months) ] [ Designated as safety issue: No ]
    Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age.

  • Serum inflammatory cytokine concentrations [ Time Frame: At birth (day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phosphorus Homeostasis [ Time Frame: At term age (expected 2-4 months) ] [ Designated as safety issue: No ]
    Measurement of serum and urine phosphorus concentrations

  • Growth parameters [ Time Frame: At term age (expected 2-4 months) ] [ Designated as safety issue: No ]
  • Vitamin D Dose Safety as Measured by Urinary Calcium Excretion [ Time Frame: At term age (expected 2-4 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 68
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 400 IU Cholecalciferol - Vitamin D Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily
Infants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached.
Placebo Comparator: Placebo
Placebo contains Fractionated Coconut Oil
 Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily
Infants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any infant born at the Medical University of South Carolina <34 weeks gestation
  • Less that 1500g at birth
  • AGA
  • Must be African American or Caucasian
  • Each infant born of twin and triplet pregnancies will be eligible

Exclusion Criteria:

  • Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion
  • Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)
  • Maternal uncontrolled thyroid disease
  • Maternal Parathyroid disease
  • Infants of races other than African American or Caucasian
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363167

Contacts
Contact: Betty Bivens 843 792-2401 bivensb@musc.edu
Contact: Sarah Taylor, MD 843-792-2112 taylorse@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Betty C Bivens     843-792-2401     bivensb@musc.edu    
Contact: Sarah N Taylor, MD     843-792-2112     taylorse@musc.edu    
Principal Investigator: Sarah N Taylor, MD            
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425-8750
Contact: Betty C Bivens     843-792-2401     bivensb@musc.edu    
Contact: Sarah N Taylor, MD     843-792-2112     taylorse@musc.edu    
Principal Investigator: Sarah N Taylor, MD            
Sponsors and Collaborators
Medical University of South Carolina
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Sarah N. Taylor, M.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Sarah N Taylor, Assistant Professor of Pediatrics, Medical University of SC, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01363167     History of Changes
Other Study ID Numbers: HR# 17217, K23RR021891
Study First Received: April 18, 2011
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
vitamin D
preterm infants
calcium
bone
parathyroid hormone

Additional relevant MeSH terms:
Nutrition Disorders
Birth Weight
Vitamin D Deficiency
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Cholecalciferol
 Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 22, 2013