Vitamin D Supplementation for Extremely Preterm Infants

Vitamin D Deficiency Clinical Trial

Official title:

Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600430
• Other study ID #: UAB Neo 006
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 14, 2012
• Last updated: February 8, 2017
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Premature Birth
• Preterm Infants
• Vitamin D Deficiency

Intervention

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
• 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
• Placebo
Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Children's Health System, Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death or Neurodevelopmental Impairment		Birth to 22-26 months of age
Primary	Total number of days alive and off respiratory support in the first 28 days	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%).	28 days
Primary	Serum vitamin D concentration	Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)	Day after birth 28
Secondary	Number of sepsis episodes treated with antibiotics for at least 5 days	Number of episodes of culture proven or clinically suspected sepsis episodes treated with antibiotics for at least 5 days	Participants will be followed for the duration of hospital stay, an expected average of 4 months
Secondary	Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis	Participants will be followed for the duration of hospital stay, an expected average of 4 months
Secondary	Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)	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%.	36 weeks gestational age corrected
Secondary	Duration of mechanical ventilation after randomization	Counted as number of days on which an infant is on mechanical ventilation for any part of a calendar day	Participants will be followed for the duration of hospital stay, an expected average of 4 months
Secondary	Days alive and off mechanical ventilation in the first 28 days after birth	Counted as days alive without mechanical ventilation for any part of a day	28 days
Secondary	Number of re-intubation events	Counted as number of reintubations for purposes of respiratory support	Participants will be followed for the duration of hospital stay, an expected average of 4 months
Secondary	Death	Cardiorespiratory failure	Participants will be followed for the duration of hospital stay, an expected average of 4 months
Secondary	Surgical necrotizing enterocolitis or intestinal perforation	Radiographic documentation of pneumatosis or intestinal perforation or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than 1.	Participants will be followed for the duration of hospital stay, an expected average of 4 months
Secondary	25(OH)D concentrations >60ng/ml (150 nmol/L)	Vitamin D measurement per blood obtained either centrally or by heel stick.	14 postnatal (+/- 2 days)
Secondary	25(OH)D concentrations >60ng/ml (150 nmol/L)	Vitamin D measurement per blood obtained either centrally or by heel stick.	28 days postnatal age (+/- 3 days)
Secondary	Serum calcium level	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.	Participants will be followed for the duration of hospital stay, an expected average of 4 months
Secondary	Urine calcium level	Calcium measurement per urine, random sampling. High level (>95%tile) urine calcium to creatinine ratio is >3.8 mmol/mmol.	Participants will be followed for the duration of hospital stay, an expected average of 4 months
Secondary	Meningitis	Culture proven or culture negative clinically treated course consistent with meningitis	Participants will be followed for the duration of hospital stay, an expected average of 4 months