Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273843
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Hesham Abdel-Hady, Mansoura University Children Hospital

Brief 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 these infants.

Condition or disease Intervention/treatment Phase
Prematurity Late-onset Sepsis Drug: High-dose vitamin D 3 Drug: Conventional-Dose Vitamin D 3 Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis
Study Start Date : September 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Vitamin D

Arm Intervention/treatment
Experimental: High-dose vitamin D
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
Drug: High-dose vitamin D 3
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
Other Name: High-dose cholecalciferol

Active Comparator: Conventional-dose vitamin D
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
Drug: Conventional-Dose Vitamin D 3
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
Other Name: Conventional-dose cholecalciferol




Primary Outcome Measures :
  1. Serum interleukin-6 [ Time Frame: At trial entry and 7 days after daily vitamin D supplementation therapy ]
    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

  2. Serum tumor necrosis-alpha [ Time Frame: At trial entry and 7 days after daily vitamin D supplementation therapy ]
    Serum levels of tumor necrosis-alpha (TNF-alpha) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy


Secondary Outcome Measures :
  1. Serum C-reactive protein (CRP) [ Time Frame: At trial entery and 7 days after daily vitamin D supplementation therapy ]
    Serum CRP will be evaluated at enrollment and 7 days

  2. Serum 25(OH)D levels [ Time Frame: at trial entry, 7 days after daily vitamin D supplementation therapy and at 40 weeks postmenstrual age ]
    Serum 25(OH)D levels will be measured by ELISA at trial entry, at day 7 and at 40 weeks postmenstrual age

  3. Serum calcium, phosphorus and urinary calcium [ Time Frame: 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 ]
    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 [ Time Frame: 40 weeks postmenstrual age ]
    Abdominal ultrasonography to detect any nephrocalcinosis will be done at 40 weeks postmenstrual age

  5. Mortality [ Time Frame: Baseline ]
    In-hospital mortality during NICU admission for an expected average of 5 weeks

  6. Neonatal morbidities [ Time Frame: Participants will be followed for the duration of hospital stay, for an expected average of 4 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Temperature instability (hypothermia, hyperthermia);
    2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
    3. Neurologic (hypotonia, lethargy, seizures);
    4. Gastrointestinal (feeding intolerance, abdominal distension).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273843


Locations
Layout table for location information
Egypt
Neonatal Intensive Care Unit, Mansoura University Children Hospital
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University Children Hospital

Publications:
Layout table for additonal information
Responsible Party: Hesham Abdel-Hady, Professor of Pediatrics, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT02273843     History of Changes
Other Study ID Numbers: MS 306
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Keywords provided by Hesham Abdel-Hady, Mansoura University Children Hospital:
Preterm
late-onset sepsis
Vitamin D
Dose
Interleukin-6
Tumor necrosis factor-alpha
Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents