Vitamin D Supplementation for Extremely Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
Children's Health System, Alabama
Information provided by (Responsible Party):
Namasivayam Ambalavanan, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01600430
First received: May 14, 2012
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.


Condition Intervention Phase
Vitamin D Deficiency
Preterm Infants
Bronchopulmonary Dysplasia
Dietary Supplement: Cholecalciferol
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Total number of days alive and off respiratory support in the first 28 days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    The total number of days alive and off respiratory support. Respiratory support is defined as need of supplemental oxygen and/or positive pressure ventilation to maintain normal target oxygen saturations (88-95%).

  • Serum vitamin D concentration [ Time Frame: Day after birth 28 ] [ Designated as safety issue: No ]
    Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)


Secondary Outcome Measures:
  • Number of sepsis episodes treated with antibiotics for at least 5 days [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Number of episodes of culture proven or clinically suspected sepsis episodes treated with antibiotics for at least 5 days

  • Sepsis [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Culture proven or culture negative clinically treated course consistent with sepsis

  • Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition) [ Time Frame: 36 weeks gestational age corrected ] [ Designated as safety issue: Yes ]
    A physiologic oxygen challenge test will be administered to infants from 36.0 weeks gestation to 37.0 weeks gestation to determine a need for supplemental oxygen to keep saturation levels between 88-95%.

  • Duration of mechanical ventilation after randomization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Counted as number of days on which an infant is on mechanical ventilation for any part of a calendar day

  • Days alive and off mechanical ventilation in the first 28 days after birth [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Counted as days alive without mechanical ventilation for any part of a day

  • Number of re-intubation events [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Counted as number of reintubations for purposes of respiratory support

  • Death [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Cardiorespiratory failure

  • Surgical necrotizing enterocolitis or intestinal perforation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Radiographic documentation of pneumatosis or intestinal perforation or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than 1.

  • 25(OH)D concentrations >60ng/ml (150 nmol/L) [ Time Frame: 14 postnatal (+/- 2 days) ] [ Designated as safety issue: Yes ]
    Vitamin D measurement per blood obtained either centrally or by heel stick.

  • 25(OH)D concentrations >60ng/ml (150 nmol/L) [ Time Frame: 28 days postnatal age (+/- 3 days) ] [ Designated as safety issue: Yes ]
    Vitamin D measurement per blood obtained either centrally or by heel stick.

  • Serum calcium level [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Serum calcium measurement per blood obtained either centrally or by heel stick, performed for clinical care. High serum calcium level is greater than 3 mmol/l of total calcium or total calcium of >12 mg/dL, or ionized calcium >2 mml/L.

  • Urine calcium level [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Calcium measurement per urine, random sampling. High level (>95%tile) urine calcium to creatinine ratio is >3.8 mmol/mmol.

  • Meningitis [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 months ] [ Designated as safety issue: Yes ]
    Culture proven or culture negative clinically treated course consistent with meningitis


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
Dietary Supplement: Cholecalciferol
200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days
Other Name: Vitamin D
Placebo Comparator: Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
Dietary Supplement: Placebo
Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days
Active Comparator: Oral Vitamin D--800 IU/day
Cholecalciferol 800 IU given orally once per day
Dietary Supplement: Cholecalciferol
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days
Other Name: Vitamin D

Detailed Description:

After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.

Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.

Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.

Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.

All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks

Exclusion Criteria:

  • Major congenital/chromosomal anomalies
  • Moribund infant with low likelihood of survival, in opinion of the clinical team
  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: NCT01600430

Contacts
Contact: Namasivayam Ambalavanan, MD 205 934-4680 ambal@uab.edu
Contact: Ariel Salas, MD 205 934-4680 asalas@peds.uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Namasivayam Ambalavanan, MD    205-934-4680    ambal@uab.edu   
Contact: Waldemar A Carlo, MD    205 934-4680    wcarlo@peds.uab.edu   
Sub-Investigator: Ariel Salas, MD         
Sub-Investigator: Tara McNair, BSN         
Sponsors and Collaborators
University of Alabama at Birmingham
Children's Health System, Alabama
Investigators
Principal Investigator: Namasivayam Ambalavanan, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Namasivayam Ambalavanan, Professor of Pediatrics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01600430     History of Changes
Other Study ID Numbers: UAB Neo 006
Study First Received: May 14, 2012
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Vitamin D
Newborn
Preterm
Supplementation
Respiratory

Additional relevant MeSH terms:
Infant, Newborn, Diseases
Infant, Premature, Diseases
Malnutrition
Nutrition Disorders
Bronchopulmonary Dysplasia
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014