Vitamin D DeficiencyNCT05694689
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
A study testing 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth in people with Vitamin D Deficiency, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 24 to 96 hours
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 96 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77555
About this study
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).
- Conditions
- Vitamin D Deficiency
- Being tested
- Placebo, 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth, Usual Care
- Keywords
- Premature infant, Vitamin D
- Medical subject headings
- Vitamin D Deficiency, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Normal saline
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 birthDietary supplement
Also called Cholecalciferol
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.
Usual CareOther
Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices
| Study group | Role | What they receive |
|---|---|---|
| Usual care plus placebo | Active comparator | 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. Receives: Dietary Supplement: Placebo; Other: Usual Care |
| Usual care plus vitamin D supplementation | Experimental | 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. Receives: Dietary Supplement: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-hydroxyvitamin D (25[OH]D) level
Measured: about 28 days after birth
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
Measured: 36 weeks postmenstrual age (or at the time of discharge home if earlier)
Secondary outcomes (34)
25-hydroxyvitamin D (25[OH]D) level
Measured: 36 weeks after birth
Length of Hospital stay
Measured: from time of birth to time of discharge (about 0 to 60 weeks after birth)
Number of participants who are still on respiratory support
Respiratory support includes supplemental oxygen and positive pressure ventilation.
Measured: 22 to 26 months corrected age
Number of days of supplemental oxygen
Measured: from time of birth to time of discharge (about 0 to 60 weeks after birth)
Number of days of mechanical ventilation
Measured: from time of birth to time of discharge (about 0 to 60 weeks after birth)
Number of days of positive pressure support
Measured: from time of birth to time of discharge (about 0 to 60 weeks after birth)
Number of participants who receive steroid treatment to decrease respiratory support
Measured: from baseline to 36 weeks postmenstrual age
Number of participants with pulmonary hypertension
Measured: 36 weeks postmenstrual age
Number of participants with wheezing
Measured: 2 years
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.
Measured: 28 days of life
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.
Measured: 36 weeks postmenstrual age
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.
Measured: 2 years
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.
Measured: 28 days of life
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.
Measured: 36 weeks postmenstrual age
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.
Measured: 2 years
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.
Measured: 28 days of life
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.
Measured: 36 weeks postmenstrual age
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.
Measured: 2 years
Number of participants with any fractures
Measured: from baseline to 36 weeks postmenstrual age
Number of participants with hospital-acquired sepsis
Measured: from day 3 after birth to the time of discharge (which is 0 to 60 weeks after birth)
Calcium level
Measured: 0 to 36 weeks postmenstrual age
Phosphorus level
Measured: 0 to 36 weeks postmenstrual age
Alkaline phosphatase level
Measured: 0 to 36 weeks postmenstrual age
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Number of participants with neurodevelopmental impairment (NDI)
Measured: 2 years
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).
Measured: 36 weeks postmenstrual age
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)
Measured: about 28 days after birth
Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS
Measured: 36 weeks postmenstrual age
Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS
Measured: 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
Measured: 36 weeks postmenstrual age
Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS
Measured: about 28 days after birth
Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS
Measured: 36 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start15 Feb 2023
- Primary completion31 Dec 2025
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria del Mar Romero López, The University of Texas Health Science Center, Houston
- Investigators
- Sunil Jain, MD, Principal investigator, The University of Texas Medical Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694689
- Sponsor's protocol ID
- IRB # 22-0217
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
- ClinicalTrials.gov ID
- NCT05694689
- Acronym / sponsor ID
- IRB # 22-0217
- Conditions
- Vitamin D Deficiency
- Keywords
- Premature infant, Vitamin D
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care plus placebo | Active comparator | Dietary Supplement: Placebo, Other: Usual CareInfants 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 vitamin D supplementation | Experimental | Dietary Supplement: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth, Other: Usual CareInfants 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. |
Who may qualify
- Ages
- 24 to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Normal salinePlacebo 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. | Dietary supplement | Usual care plus placebo |
| 800 IU/day vitamin D supplementation with feedings in the first 28 days after birthAlso: Cholecalciferol800 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. | Dietary supplement | Usual care plus vitamin D supplementation |
| Usual CareCo-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices | Other | Usual care plus placebo, Usual care plus vitamin D supplementation |
Primary outcome
25-hydroxyvitamin D (25[OH]D) level
Time frame: about 28 days after birth
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
34 secondary outcomes
25-hydroxyvitamin D (25[OH]D) level
Time frame: 36 weeks after birth
Length of Hospital stay
Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)
Number of participants who are still on respiratory support
Time frame: 22 to 26 months corrected age
Number of days of supplemental oxygen
Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)
Number of days of mechanical ventilation
Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)
Number of days of positive pressure support
Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)
Number of participants who receive steroid treatment to decrease respiratory support
Time frame: from baseline to 36 weeks postmenstrual age
Number of participants with pulmonary hypertension
Time frame: 36 weeks postmenstrual age
Number of participants with wheezing
Time frame: 2 years
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 28 days of life
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 36 weeks postmenstrual age
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 2 years
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 28 days of life
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 36 weeks postmenstrual age
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 2 years
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 28 days of life
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 36 weeks postmenstrual age
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Time frame: 2 years
Number of participants with any fractures
Time frame: from baseline to 36 weeks postmenstrual age
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)
Calcium level
Time frame: 0 to 36 weeks postmenstrual age
Phosphorus level
Time frame: 0 to 36 weeks postmenstrual age
Alkaline phosphatase level
Time frame: 0 to 36 weeks postmenstrual age
Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Cognitive composite score)
Time frame: 2 years
Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Language composite score)
Time frame: 2 years
Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Motor composite score)
Time frame: 2 years
Number of participants with neurodevelopmental impairment (NDI)
Time frame: 2 years
Number of participants who die or have a morbidity
Time frame: 36 weeks postmenstrual age
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
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
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
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
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
Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS
Time frame: 36 weeks postmenstrual age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Jain, MD principal investigator
The University of Texas Medical Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth in people with Vitamin D Deficiency, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25-hydroxyvitamin D (25[OH]D) level (time frame: about 28 days after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.