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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Vitamin D Deficiency; Asthma; Bronchiolitis; Other Preterm Infants
• Intervention / Treatment: Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • P.O.Box 151
    • Beer- Sheva, P.O.Box 151, Israel, 84101
      • Soroka University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily)	12 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory morbidity prevalence	Reports given by the parents via questionnaire at 3, 6, 9 and 12 months.	first year
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	first year
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).	first year

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Principal Investigator: Inbal Golan Tripto, MD, Soroka University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): February 12, 2018
• Study Completion (Actual): February 12, 2018

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Vitamin D; prematurity; Respiratory Morbidity
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Lung Diseases, Obstructive; Bronchitis; Vitamin D Deficiency; Bronchiolitis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: SOR -0292-14-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES