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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sarah N Taylor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01363167
First received: April 18, 2011
Last updated: July 8, 2013
Last verified: July 2013
  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:


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: October 2013
Estimated Primary Completion Date: October 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363167

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-8750
Sponsors and Collaborators
Medical University of South Carolina
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: July 8, 2013
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:
Birth Weight
Vitamin D Deficiency
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 29, 2014