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Completed

NCT Number: NCT02404623

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

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.

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Key information

Conditions

Other Preterm Infants Asthma Avitaminosis Bronchial Diseases Bronchiolitis Bronchitis Deficiency Diseases Female Urogenital Diseases and Pregnancy Complications Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pneumonia Pregnancy Complications Premature Birth Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Vitamin D Deficiency

Age range

33 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka University Medical Center

Beersheba, P.O.Box 151, 84101, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

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 outcomes

  1. 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 outcomes

  1. respiratory morbidity prevalence

    Time frame: first year

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

  2. 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

  3. 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).

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2015
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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