Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05694689

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Female Urogenital Diseases and Pregnancy Complications Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 hour–96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

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.

Other names: Normal saline

800 IU/day vitamin D supplementation with feedings in the first 28 days after birth

Dietary Supplement

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 names: Cholecalciferol

Usual Care

Other

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

Primary outcomes

  1. 25-hydroxyvitamin D (25[OH]D) level

    Time frame: about 28 days after birth

  2. Type of respiratory support required at 36 weeks postmenstrual age

    Time frame: 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

Secondary outcomes

  1. 25-hydroxyvitamin D (25[OH]D) level

    Time frame: 36 weeks after birth

  2. Length of Hospital stay

    Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)

  3. Number of participants who are still on respiratory support

    Time frame: 22 to 26 months corrected age

    Respiratory support includes supplemental oxygen and positive pressure ventilation.

  4. Number of days of supplemental oxygen

    Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)

  5. Number of days of mechanical ventilation

    Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)

  6. Number of days of positive pressure support

    Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)

  7. Number of participants who receive steroid treatment to decrease respiratory support

    Time frame: from baseline to 36 weeks postmenstrual age

  8. Number of participants with pulmonary hypertension

    Time frame: 36 weeks postmenstrual age

  9. Number of participants with wheezing

    Time frame: 2 years

  10. Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 28 days of life

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  11. Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 36 weeks postmenstrual age

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  12. Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 2 years

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  13. Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 28 days of life

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  14. Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 36 weeks postmenstrual age

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  15. Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 2 years

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  16. Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 28 days of life

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  17. Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 36 weeks postmenstrual age

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  18. Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

    Time frame: 2 years

    Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.

  19. Number of participants with any fractures

    Time frame: from baseline to 36 weeks postmenstrual age

  20. Number of participants with hospital-acquired sepsis

    Time frame: from day 3 after birth to the time of discharge (which is 0 to 60 weeks after birth)

  21. Calcium level

    Time frame: 0 to 36 weeks postmenstrual age

  22. Phosphorus level

    Time frame: 0 to 36 weeks postmenstrual age

  23. Alkaline phosphatase level

    Time frame: 0 to 36 weeks postmenstrual age

  24. Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Cognitive composite score)

    Time frame: 2 years

    Cognitive composite score ranges from 40 to 160, with a higher score indicating a better outcome.

  25. Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Language composite score)

    Time frame: 2 years

    Language composite score ranges from 40 to 160, with a higher score indicating a better outcome.

  26. Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Motor composite score)

    Time frame: 2 years

    Motor composite score ranges from 40 to 160, with a higher score indicating a better outcome.

  27. Number of participants with neurodevelopmental impairment (NDI)

    Time frame: 2 years

  28. Number of participants who die or have a morbidity

    Time frame: 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).

  29. 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)

    Time frame: about 28 days after birth

  30. Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS

    Time frame: 36 weeks postmenstrual age

  31. Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS

    Time frame: about 28 days after birth

  32. Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS

    Time frame: 36 weeks postmenstrual age

  33. Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS

    Time frame: about 28 days after birth

  34. Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS

    Time frame: 36 weeks postmenstrual age

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Jan 23, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.