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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

April 18, 2011
November 18, 2011
October 2011
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01363167 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
Identifying Vit D Deficiency in VLBW Infants Part 2

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Infant, Very Low Birth Weight
  • Calcium Deficiency
  • Vitamin D Deficiency
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.
  • Active Comparator: 400 IU Cholecalciferol - Vitamin D
    Intervention: Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily
  • Placebo Comparator: Placebo
    Placebo contains Fractionated Coconut Oil
    Intervention: Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
up to 3 Days
No
Contact: Betty Bivens 843 792-2401 bivensb@musc.edu
Contact: Sarah Taylor, MD 843-792-2112 taylorse@musc.edu
United States
 
NCT01363167
HR# 17217, K23RR021891
Yes
Sarah N Taylor, Medical University of South Carolina
Medical University of South Carolina
National Center for Research Resources (NCRR)
Principal Investigator: Sarah N. Taylor, M.D. Medical University of South Carolina
Medical University of South Carolina
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP