Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

Not Applicable

Recruiting

• Conditions: Vitamin D Deficiency

• Registration Number: NCT05694689
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-23
• Study Start: 2023-02-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-09-29
• Primary Completion: 2026-01-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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 die
Number 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
Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS	36 weeks postmenstrual age

Trial Locations

Locations (1)

The University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States