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

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ClinicalTrials.gov Identifier: NCT01363167
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : November 24, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Infant, Very Low Birth Weight Calcium Deficiency Vitamin D Deficiency Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Identifying Vit D Deficiency in VLBW Infants Part 2
Study Start Date : October 2011
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Intestinal Calcium Absorption [ Time Frame: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth ]
  2. Parathyroid hormone concentration [ Time Frame: At term age (expected 2-4 months) ]
  3. Serum 25 hydroxyvitamin D status [ Time Frame: At term age (expected 2-4 months) ]
  4. 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.

  5. Serum inflammatory cytokine concentrations [ Time Frame: At birth (day 1) ]

Secondary Outcome Measures :
  1. Phosphorus Homeostasis [ Time Frame: At term age (expected 2-4 months) ]
    Measurement of serum and urine phosphorus concentrations

  2. Growth parameters [ Time Frame: At term age (expected 2-4 months) ]
  3. Vitamin D Dose Safety as Measured by Urinary Calcium Excretion [ Time Frame: At term age (expected 2-4 months) ]

Eligibility Criteria

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363167


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-8750
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
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

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 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 2014

Keywords provided by Sarah N Taylor, 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
Bone Density Conservation Agents