Clinical trial NCT05694689: Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
Official title: Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Premature infant
Vitamin D
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 24
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).


Eligibility criteria: Inclusion Criteria:

* Infants born at \< 28 weeks gestational age (GA) or \<1000 grams birth weight (BW)
* Inborn
* Informed written consent in an Institutional Review Board (IRB)-approved manner

Exclusion Criteria:

* GA \>32 weeks regardless of birth weight (BW)
* Any major congenital anomaly
* An known congenital nonbacterial infection
* Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
* Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.

Primary outcomes:
measure: 25-hydroxyvitamin D (25[OH]D) level
timeFrame: about 28 days after birth
Secondary outcomes:
measure: 25-hydroxyvitamin D (25[OH]D) level
timeFrame: 36 weeks after birth
measure: Type of respiratory support required at 36 weeks postmenstrual age
timeFrame: 36 weeks postmenstrual age (or at the time of discharge home if earlier)
measure: Length of Hospital stay
timeFrame: from time of birth to time of discharge (about 0 to 60 weeks after birth)
measure: Number of participants who are still on respiratory support
timeFrame: 22 to 26 months corrected age
measure: Number of days of supplemental oxygen
timeFrame: from time of birth to time of discharge (about 0 to 60 weeks after birth)
measure: Number of days of mechanical ventilation
timeFrame: from time of birth to time of discharge (about 0 to 60 weeks after birth)
measure: Number of days of positive pressure support
timeFrame: from time of birth to time of discharge (about 0 to 60 weeks after birth)
measure: Number of participants who receive steroid treatment to decrease respiratory support
timeFrame: from baseline to 36 weeks postmenstrual age
measure: Number of participants with pulmonary hypertension
timeFrame: 36 weeks postmenstrual age
measure: Number of participants with wheezing
timeFrame: 2 years
measure: Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 28 days of life
measure: Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 36 weeks postmenstrual age
measure: Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 2 years
measure: Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 28 days of life
measure: Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 36 weeks postmenstrual age
measure: Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 2 years
measure: Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 28 days of life
measure: Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 36 weeks postmenstrual age
measure: Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
timeFrame: 2 years
measure: Number of participants with any fractures
timeFrame: from baseline to 36 weeks postmenstrual age
measure: Number of participants with hospital-acquired sepsis
timeFrame: from day 3 after birth to the time of discharge (which is 0 to 60 weeks after birth)
measure: Calcium level
timeFrame: 0 to 36 weeks postmenstrual age
measure: Phosphorus level
timeFrame: 0 to 36 weeks postmenstrual age
measure: Alkaline phosphatase level
timeFrame: 0 to 36 weeks postmenstrual age
measure: Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Cognitive composite score)
timeFrame: 2 years
measure: Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Language composite score)
timeFrame: 2 years
measure: Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Motor composite score)
timeFrame: 2 years
measure: Number of participants with neurodevelopmental impairment (NDI)
timeFrame: 2 years
measure: Number of participants who die or have a morbidity
timeFrame: 36 weeks postmenstrual age
measure: Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by Liquid Chromatography with tandem mass spectrometry (LC-MS/MS)
timeFrame: about 28 days after birth
measure: Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS
timeFrame: 36 weeks postmenstrual age
measure: Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS
timeFrame: about 28 days after birth
measure: Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS
timeFrame: 36 weeks postmenstrual age
measure: Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS
timeFrame: about 28 days after birth
measure: Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS
timeFrame: 36 weeks postmenstrual age
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch
name: Sunil Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: