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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694689
• Other study ID #: IRB # 22-0217
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Sunil Jain, MD
• Phone: 409-772-2815
• Email: skjain[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Hours to 96 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Placebo
Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution.
• 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
800 IU/day Vitamin D supplementation until 400 IU/ day are provided as part of usual care. At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings.

Other:
• Usual Care
Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxyvitamin D (25[OH]D) level		about 28 days after birth
Secondary	25-hydroxyvitamin D (25[OH]D) level		36 weeks after birth
Secondary	Type of respiratory support required at 36 weeks postmenstrual age	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	36 weeks postmenstrual age (or at the time of discharge home if earlier)
Secondary	Length of Hospital stay		from time of birth to time of discharge (about 0 to 60 weeks after birth)
Secondary	Number of participants who are still on respiratory support	Respiratory support includes supplemental oxygen and positive pressure ventilation.	22 to 26 months corrected age
Secondary	Number of days of supplemental oxygen		from time of birth to time of discharge (about 0 to 60 weeks after birth)
Secondary	Number of days of mechanical ventilation		from time of birth to time of discharge (about 0 to 60 weeks after birth)
Secondary	Number of days of positive pressure support		from time of birth to time of discharge (about 0 to 60 weeks after birth)
Secondary	Number of participants who receive steroid treatment to decrease respiratory support		from baseline to 36 weeks postmenstrual age
Secondary	Number of participants with pulmonary hypertension		36 weeks postmenstrual age
Secondary	Number of participants with wheezing		2 years
Secondary	Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	28 days of life
Secondary	Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	36 weeks postmenstrual age
Secondary	Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	2 years
Secondary	Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	28 days of life
Secondary	Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	36 weeks postmenstrual age
Secondary	Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	2 years
Secondary	Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	28 days of life
Secondary	Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	36 weeks postmenstrual age
Secondary	Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator	Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.	2 years
Secondary	Number of participants with any fractures		from baseline to 36 weeks postmenstrual age
Secondary	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)
Secondary	Calcium level		0 to 36 weeks postmenstrual age
Secondary	Phosphorus level		0 to 36 weeks postmenstrual age
Secondary	Alkaline phosphatase level		0 to 36 weeks postmenstrual age
Secondary	Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Cognitive composite score)	Cognitive composite score ranges from 40 to 160, with a higher score indicating a better outcome.	2 years
Secondary	Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Language composite score)	Language composite score ranges from 40 to 160, with a higher score indicating a better outcome.	2 years
Secondary	Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Motor composite score)	Motor composite score ranges from 40 to 160, with a higher score indicating a better outcome.	2 years
Secondary	Number of participants with neurodevelopmental impairment (NDI)		2 years
Secondary	Number of participants who die or have a morbidity	Morbidities include retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), neurodevelopmental impairment (NDI), necrotizing enterocolitis (NEC), and patent ductus arteriosus (PDA).	36 weeks postmenstrual age
Secondary	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
Secondary	Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS		36 weeks postmenstrual age
Secondary	Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS		about 28 days after birth
Secondary	Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS		36 weeks postmenstrual age
Secondary	Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS		about 28 days after birth
Secondary	Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS		36 weeks postmenstrual age