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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01363167
First Posted: June 1, 2011
Last Update Posted: November 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Sarah N Taylor, Medical University of South Carolina
April 18, 2011
June 1, 2011
November 24, 2014
October 2011
October 2013   (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 ]
  • Parathyroid hormone concentration [ Time Frame: At term age (expected 2-4 months) ]
  • Serum 25 hydroxyvitamin D status [ Time Frame: At term age (expected 2-4 months) ]
  • Bone Health [ Time Frame: At term age (expected 2-4 months) ]
    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) ]
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) ]
    Measurement of serum and urine phosphorus concentrations
  • Growth parameters [ Time Frame: At term age (expected 2-4 months) ]
  • Vitamin D Dose Safety as Measured by Urinary Calcium Excretion [ Time Frame: At term age (expected 2-4 months) ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
 
Completed
68
October 2013
October 2013   (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
Sexes Eligible for Study: All
up to 3 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01363167
HR# 17217
K23RR021891 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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 2014

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