Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birthDietary Supplement: PlaceboOther: Usual Care
- Registration Number
- NCT05694689
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care plus vitamin D supplementation Usual Care Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day. At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day. Usual care plus vitamin D supplementation 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day. At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day. Usual care plus placebo Placebo Infants will receive placebo (normal saline) in the first 28 days after birth. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. Usual care plus placebo Usual Care Infants will receive placebo (normal saline) in the first 28 days after birth. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices.
- Primary Outcome Measures
Name Time Method 25-hydroxyvitamin D (25[OH]D) level about 28 days after birth
- Secondary Outcome Measures
Name Time Method Phosphorus level 0 to 36 weeks postmenstrual age Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS 36 weeks postmenstrual age Number of days of supplemental oxygen from time of birth to time of discharge (about 0 to 60 weeks after birth) Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS 36 weeks postmenstrual age Length of Hospital stay from time of birth to time of discharge (about 0 to 60 weeks after birth) Number of participants who are still on respiratory support 22 to 26 months corrected age Respiratory support includes supplemental oxygen and positive pressure ventilation.
Number of participants with pulmonary hypertension 36 weeks postmenstrual age 25-hydroxyvitamin D (25[OH]D) level 36 weeks after birth Number of participants with neurodevelopmental impairment (NDI) 2 years Number of days of mechanical ventilation from time of birth to time of discharge (about 0 to 60 weeks after birth) Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator 2 years Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Number of participants with hospital-acquired sepsis from day 3 after birth to the time of discharge (which is 0 to 60 weeks after birth) Calcium level 0 to 36 weeks postmenstrual age Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Language composite score) 2 years Language composite score ranges from 40 to 160, with a higher score indicating a better outcome.
Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS 36 weeks postmenstrual age Type of respiratory support required at 36 weeks postmenstrual age 36 weeks postmenstrual age (or at the time of discharge home if earlier) Data will be reported categorically as:
* Number of participants who survive without respiratory support
* Number of participants who survive with nasal cannula at ≤ 2 liters (L)/minute
* Number of participants who survive with nasal cannula \>2 L/minute or noninvasive positive airway pressure
* Number of participants who survive with invasive mechanical ventilation
* Number of participants who dieNumber of participants with wheezing 2 years Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator 2 years Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Alkaline phosphatase level 0 to 36 weeks postmenstrual age Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Motor composite score) 2 years Motor composite score ranges from 40 to 160, with a higher score indicating a better outcome.
Number of days of positive pressure support from time of birth to time of discharge (about 0 to 60 weeks after birth) Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator 2 years Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Number of participants who receive steroid treatment to decrease respiratory support from baseline to 36 weeks postmenstrual age Number of participants with any fractures from baseline to 36 weeks postmenstrual age Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Cognitive composite score) 2 years Cognitive composite score ranges from 40 to 160, with a higher score indicating a better outcome.
Number of participants who die or have a morbidity 36 weeks postmenstrual age Morbidities include retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), neurodevelopmental impairment (NDI), necrotizing enterocolitis (NEC), and patent ductus arteriosus (PDA).
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) about 28 days after birth
Trial Locations
- Locations (1)
The University of Texas Medical Branch
🇺🇸Galveston, Texas, United States