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The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity

This study is currently recruiting participants.
Verified March 2017 by Inbal Golan- Tripto MD, Soroka University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02404623
First Posted: March 31, 2015
Last Update Posted: March 30, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Inbal Golan- Tripto MD, Soroka University Medical Center
  Purpose

This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants.

This is a prospective randomized (1:1) double-blinded trial.

The study population will be randomized into two groups (1:1):

  • Intervention Group - 800 IU of Vitamin D once daily
  • Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year after randomization for serum Vitamin D levels and respiratory morbidity.

Condition Intervention
Other Preterm Infants Vitamin D Deficiency Bronchiolitis Asthma Pneumonia Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life

Resource links provided by NLM:


Further study details as provided by Inbal Golan- Tripto MD, Soroka University Medical Center:

Primary Outcome Measures:
  • Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily) [ Time Frame: 12 months of age ]

Secondary Outcome Measures:
  • respiratory morbidity prevalence [ Time Frame: first year ]
    Reports given by the parents via questionnaire at 3, 6, 9 and 12 months.

  • respiratory morbidity prevalence [ Time Frame: first year ]
    Information collected from medical records containing the data of diagnosis or admission to pediatrics departments due to: bronchiolitis, wheezing, upper or lower respiratory tract infections, asthma and pneumonia

  • respiratory morbidity prevalence [ Time Frame: first year ]
    Information collected from medical records containing the data of medication consumption such as bronchodilators, inhaled corticosteroid, systemic corticosteroids (along with respiratory disease) and antibiotics (along with respiratory infection).


Estimated Enrollment: 60
Study Start Date: April 2015
Estimated Study Completion Date: May 16, 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
800 IU of Vitamin D once daily
Dietary Supplement: Vitamin D
also known as Cholecalciferol, is one of the two most important compounds within the group of Vitamin D. It can be ingested from the diet and from supplements. In this study it is pharmacologically acquired and referred to as Vitamin D
Control Group
400 IU of Vitamin D once daily, the standard of care
Dietary Supplement: Vitamin D
also known as Cholecalciferol, is one of the two most important compounds within the group of Vitamin D. It can be ingested from the diet and from supplements. In this study it is pharmacologically acquired and referred to as Vitamin D

Detailed Description:

The rational of this trial is that a daily supplementation of a double dose of Vitamin D (800 IU instead of 400 IU) to late premature infants during the first year of life will result in elevated Vitamin D serum levels and in an improvement in respiratory morbidity.

This randomized trial of vitamin D supplementation is planned to determine the optimal dose of daily vitamin D supplementation required to achieve sufficient vitamin D levels in preterm infants and to assess whether doubling the daily intake of vitamin D may serve as primary prevention of respiratory infections and asthma in premature infants.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   33 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Preterm infant born at 32+6 to 36+6 weeks of gestational age
  2. Born at Soroka University Medical Center
  3. Signed informed consent
  4. Participants in the trial will be insured by "Clalit" HMO

Exclusion Criteria:

  1. Chromosomal abnormality
  2. Neurological or muscular congenital anomalies
  3. Congenital cardiac defect
  4. Congenital respiratory anomalies
  5. Congenital GIT/ liver/ renal anomalies that effect the absorption and/or metabolism of Vitamin D and/or other substances.
  6. Admission after birth to NICU persists more than 5 days
  Contacts and Locations
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): NCT02404623


Contacts
Contact: Inbal Golan Tripto, MD 972-8-6400755 InbalGT@clalit.org.il

Locations
Israel
Soroka University Medical Center Recruiting
Beer- Sheva, P.O.Box 151, Israel, 84101
Contact: Inbal Golan-Tripto, MD    054-5424654    InbalGT@clalit.org.il   
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Inbal Golan Tripto, MD Soroka University Medical Center
  More Information

Responsible Party: Inbal Golan- Tripto MD, Pediatrics pulmonologist, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02404623     History of Changes
Other Study ID Numbers: SOR -0292-14-CTIL
First Submitted: March 18, 2015
First Posted: March 31, 2015
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Inbal Golan- Tripto MD, Soroka University Medical Center:
Vitamin D
Respiratory Morbidity
prematurity

Additional relevant MeSH terms:
Pneumonia
Bronchiolitis
Vitamin D Deficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents