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Vitamin D DeficiencyPhase 2/3NCT01600430

Vitamin D Supplementation for Extremely Preterm Infants

A Phase 2/3 study testing Cholecalciferol in people with Vitamin D Deficiency and Preterm Infants, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants. Read more about this study

Who is it for?
Ages 1 minute to 7 days
What is being tested?
Cholecalciferol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
Jun 2012to Dec 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

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 1 minute to 7 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks

Who cannot join

  • Major congenital/chromosomal anomalies
  • Moribund infant with low likelihood of survival, in opinion of the clinical team

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

Other trials in United States

About this study

Official title: Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial

The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.

Read the detailed description

After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.

Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.

Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.

Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.

All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.

Being tested
Cholecalciferol, Placebo
Keywords
Vitamin D, Newborn, Preterm, Supplementation, Respiratory
Medical subject headings
Vitamin D Deficiency, Bronchopulmonary Dysplasia, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholecalciferolDietary supplement

    Also called Vitamin D

    200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days

  • CholecalciferolDietary supplement

    Also called Vitamin D

    800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days

  • PlaceboDietary supplement

    Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days

Study groups in NCT01600430
Study groupRoleWhat they receive
Oral Vitamin D--200 IU/dayActive comparatorCholecalciferol 200 IU given orally once per day
Receives: Dietary Supplement: Cholecalciferol
PlaceboPlacebo comparatorIdentical-appearing treatment that does not contain the test drug given orally four times per day.
Receives: Dietary Supplement: Placebo
Oral Vitamin D--800 IU/dayActive comparatorCholecalciferol 800 IU given orally once per day
Receives: Dietary Supplement: Cholecalciferol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total number of days alive and off respiratory support in the first 28 days

    The total number of days alive and off respiratory support. Respiratory support is defined as need of supplemental oxygen and/or positive pressure ventilation to maintain normal target oxygen saturations (88-95%).

    Measured: 28 days

  2. Serum vitamin D concentration

    Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)

    Measured: Day after birth 28

Secondary outcomes (13)

  1. Number of sepsis episodes treated with antibiotics for at least 5 days

    Number of episodes of culture proven or clinically suspected sepsis episodes treated with antibiotics for at least 5 days

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

  2. Sepsis

    Culture proven or culture negative clinically treated course consistent with sepsis

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

  3. Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)

    A physiologic oxygen challenge test will be administered to infants from 36.0 weeks gestation to 37.0 weeks gestation to determine a need for supplemental oxygen to keep saturation levels between 88-95%.

    Measured: 36 weeks gestational age corrected

  4. Duration of mechanical ventilation after randomization

    Counted as number of days on which an infant is on mechanical ventilation for any part of a calendar day

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

  5. Days alive and off mechanical ventilation in the first 28 days after birth

    Counted as days alive without mechanical ventilation for any part of a day

    Measured: 28 days

  6. Number of re-intubation events

    Counted as number of reintubations for purposes of respiratory support

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

  7. Death

    Cardiorespiratory failure

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

  8. Surgical necrotizing enterocolitis or intestinal perforation

    Radiographic documentation of pneumatosis or intestinal perforation or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than 1.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

  9. 25(OH)D concentrations >60ng/ml (150 nmol/L)

    Vitamin D measurement per blood obtained either centrally or by heel stick.

    Measured: 14 postnatal (+/- 2 days)

  10. 25(OH)D concentrations >60ng/ml (150 nmol/L)

    Vitamin D measurement per blood obtained either centrally or by heel stick.

    Measured: 28 days postnatal age (+/- 3 days)

  11. Serum calcium level

    Serum calcium measurement per blood obtained either centrally or by heel stick, performed for clinical care. High serum calcium level is greater than 3 mmol/l of total calcium or total calcium of >12 mg/dL, or ionized calcium >2 mml/L.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

  12. Urine calcium level

    Calcium measurement per urine, random sampling. High level (>95%tile) urine calcium to creatinine ratio is >3.8 mmol/mmol.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

  13. Meningitis

    Culture proven or culture negative clinically treated course consistent with meningitis

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2014
  4. Study completionDec 2016

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01600430
Sponsor's protocol ID
UAB Neo 006
Status last verified
Feb 2017
First submitted
14 May 2012
Last updated
10 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Aristizabal N, Holder MP, Durham L, Ashraf AP, Taylor S, Salas AA. Safety and Efficacy of Early Vitamin D Supplementation in Critically Ill Extremely Preterm Infants: An Ancillary Study of a Randomized Trial. J Acad Nutr Diet. 2023 Jan;123(1):87-94. doi: 10.1016/j.jand.2022.06.012. Epub 2022 Jun 18.

    PubMed 35728797

  • Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

    PubMed 33305842

  • Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.

    PubMed 27079965

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cholecalciferol in people with Vitamin D Deficiency and Preterm Infants, run by University of Alabama at Birmingham 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 Feb 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Total number of days alive and off respiratory support in the first 28 days (time frame: 28 days). 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?

On the ClinicalTrials.gov record for NCT01600430, which also lists 3 linked publications.

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 10 Feb 2017.

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