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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404623
• Other study ID #: SOR -0292-14-CTIL
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: February 13, 2018
• Start date: April 2015
• Est. completion date: February 12, 2018

Study information

• Verified date: February 2018
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 12, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 33 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchiolitis
• Other Preterm Infants
• Pneumonia
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer- Sheva	P.O.Box 151

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	respiratory morbidity prevalence	Reports given by the parents via questionnaire at 3, 6, 9 and 12 months.	first year
Secondary	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
Secondary	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