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PrematurityPhase 1NCT02273843

A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis

A Phase 1 study testing High-dose vitamin D 3 and Conventional-Dose Vitamin D 3 in people with Prematurity and Late-onset Sepsis, run by Mansoura University Children Hospital at 1 site in Egypt.

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

This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of… Read more about this study

Who is it for?
Ages 3 to 28 days
Conditions the study is for
Prematurity, Late-onset Sepsis
What is being tested?
High-dose vitamin D 3 and Conventional-Dose Vitamin D 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
Sep 2013to Aug 2015
Phase
Phase 1
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 3 to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Preterm Infants (28-37 wk gestational age)
  • Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:
  • Temperature instability (hypothermia, hyperthermia);
  • Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
  • Neurologic (hypotonia, lethargy, seizures);
  • Gastrointestinal (feeding intolerance, abdominal distension).

Who cannot join

  • Major congenital anomalies.
  • Chromosomal anomalies.
  • Known inborn error(s) of metabolism

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Neonatal Intensive Care Unit, Mansoura University Children Hospital

    Al Mansurah, Dakahlia Governorate, 35516

Other trials in Egypt

About this study

Official title: Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis

This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.

Read the detailed description

Vitamin D has an important role in the regulation of both the innate and adaptive immune systems. There are very few studies of such roles in the neonatal population. It is potentially an attractive therapeutic agent for sepsis given its low cost and low risk of toxicity and side effects. There is no consensus regarding to the dose of vitamin D supplementation required for preterm infants given the paucity of evidence. AAP and ESPGHAN have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day. The influence of different doses of vitamin D on immunological status and clinical outcomes of preterm infants with late-onset sepsis has not been evaluated before. This RCT will evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis we will also evaluate their safety and influence on clinical outcomes of these infants

Being tested
High-dose vitamin D 3, Conventional-Dose Vitamin D 3
Keywords
Preterm, late-onset sepsis, Vitamin D, Dose, Interleukin-6, Tumor necrosis factor-alpha
Medical subject headings
Premature Birth

What participants receive

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

  • High-dose vitamin D 3Drug

    Also called High-dose cholecalciferol

    Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU

  • Conventional-Dose Vitamin D 3Drug

    Also called Conventional-dose cholecalciferol

    Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU

Study groups in NCT02273843
Study groupRoleWhat they receive
High-dose vitamin DExperimentalWill receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU
Receives: Drug: High-dose vitamin D 3
Conventional-dose vitamin DActive comparatorWill receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU
Receives: Drug: Conventional-Dose Vitamin D 3

What is being measured

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

  1. Serum interleukin-6

    Serum levels of interleukin-6 (IL-6) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy. IL-6 concentrations will be determined by Endogenous Interleukin-ELISA

    Measured: At trial entry and 7 days after daily vitamin D supplementation therapy

  2. Serum tumor necrosis-alpha

    Serum levels of tumor necrosis-alpha (TNF-alpha) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy

    Measured: At trial entry and 7 days after daily vitamin D supplementation therapy

Secondary outcomes (6)

  1. Serum C-reactive protein (CRP)

    Serum CRP will be evaluated at enrollment and 7 days

    Measured: At trial entery and 7 days after daily vitamin D supplementation therapy

  2. Serum 25(OH)D levels

    Serum 25(OH)D levels will be measured by ELISA at trial entry, at day 7 and at 40 weeks postmenstrual age

    Measured: at trial entry, 7 days after daily vitamin D supplementation therapy and at 40 weeks postmenstrual age

  3. Serum calcium, phosphorus and urinary calcium

    Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks

    Measured: Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks

  4. Abdominal ultrasonography

    Abdominal ultrasonography to detect any nephrocalcinosis will be done at 40 weeks postmenstrual age

    Measured: 40 weeks postmenstrual age

  5. Mortality

    In-hospital mortality during NICU admission for an expected average of 5 weeks

    Measured: Baseline

  6. Neonatal morbidities

    Participants will be followed for the duration of hospital stay, for an expected average of 5 weeks and the incidence of neonatal morbidities e.g. NEC, retinopathy of prematurity, disseminated intravascular coagulopathy and renal dysfunction will be assessed

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

Timeline

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

  1. First posted24 Oct 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02273843
Sponsor's protocol ID
MS 306
Status last verified
Sep 2015
First submitted
20 Oct 2014
Last updated
30 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Moromizato T, Litonjua AA, Braun AB, Gibbons FK, Giovannucci E, Christopher KB. Association of low serum 25-hydroxyvitamin D levels and sepsis in the critically ill. Crit Care Med. 2014 Jan;42(1):97-107. doi: 10.1097/CCM.0b013e31829eb7af.

    PubMed 23982028

  • Hewison M. Vitamin D and the immune system: new perspectives on an old theme. Endocrinol Metab Clin North Am. 2010 Jun;39(2):365-79, table of contents. doi: 10.1016/j.ecl.2010.02.010.

    PubMed 20511058

  • Kim SY. The pleiomorphic actions of vitamin D and its importance for children. Ann Pediatr Endocrinol Metab. 2013 Jun;18(2):45-54. doi: 10.6065/apem.2013.18.2.45. Epub 2013 Jun 30.

    PubMed 24904851

  • Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.

    PubMed 19881390

  • Abrams SA; Committee on Nutrition. Calcium and vitamin d requirements of enterally fed preterm infants. Pediatrics. 2013 May;131(5):e1676-83. doi: 10.1542/peds.2013-0420. Epub 2013 Apr 29.

    PubMed 23629620

  • 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

  • Abdel-Hady H, Yahia S, Megahed A, Mosbah A, Seif B, Nageh E, Bhattacharjee I, Aly H. Mediators in Preterm Infants With Late-onset Sepsis: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2019 Apr;68(4):578-584. doi: 10.1097/MPG.0000000000002238.

    PubMed 30896608

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing High-dose vitamin D 3 and Conventional-Dose Vitamin D 3 in people with Prematurity and Late-onset Sepsis, run by Mansoura University Children Hospital at 1 site in Egypt.

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 6 inclusion and 3 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 30 Sep 2015. 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 Egypt. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Serum interleukin-6 (time frame: At trial entry and 7 days after daily vitamin D supplementation therapy). 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 NCT02273843, which also lists 7 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 30 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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