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

Primary Purpose

Other Preterm Infants, Vitamin D Deficiency, Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Other Preterm Infants focused on measuring Vitamin D, Respiratory Morbidity, prematurity

Eligibility Criteria

33 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Soroka University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

800 IU of Vitamin D once daily

400 IU of Vitamin D once daily, the standard of care

Outcomes

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)

Secondary Outcome Measures

respiratory morbidity prevalence
Reports given by the parents via questionnaire at 3, 6, 9 and 12 months.
respiratory morbidity prevalence
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
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).

Full Information

First Posted
March 18, 2015
Last Updated
February 13, 2018
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02404623
Brief Title
The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity
Official Title
The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 12, 2018 (Actual)
Study Completion Date
February 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Preterm Infants, Vitamin D Deficiency, Bronchiolitis, Asthma, Pneumonia
Keywords
Vitamin D, Respiratory Morbidity, prematurity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
800 IU of Vitamin D once daily
Arm Title
Control Group
Arm Type
Other
Arm Description
400 IU of Vitamin D once daily, the standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
respiratory morbidity prevalence
Description
Reports given by the parents via questionnaire at 3, 6, 9 and 12 months.
Time Frame
first year
Title
respiratory morbidity prevalence
Description
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
Time Frame
first year
Title
respiratory morbidity prevalence
Description
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).
Time Frame
first year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
33 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Preterm infant born at 32+6 to 36+6 weeks of gestational age Born at Soroka University Medical Center Signed informed consent Participants in the trial will be insured by "Clalit" HMO Exclusion Criteria: Chromosomal abnormality Neurological or muscular congenital anomalies Congenital cardiac defect Congenital respiratory anomalies Congenital GIT/ liver/ renal anomalies that effect the absorption and/or metabolism of Vitamin D and/or other substances. Admission after birth to NICU persists more than 5 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inbal Golan Tripto, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer- Sheva
State/Province
P.O.Box 151
ZIP/Postal Code
84101
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33305842
Citation
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.
Results Reference
derived

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

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