NCT02404623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

2.9 years

First QC Date

March 18, 2015

Last Update Submit

February 13, 2018

Conditions

Other Preterm InfantsVitamin D DeficiencyBronchiolitisAsthmaPneumonia

Keywords

Vitamin DRespiratory Morbidityprematurity

Outcome Measures

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)

    12 months of age

Secondary Outcomes (3)

  • respiratory morbidity prevalence

    first year

  • respiratory morbidity prevalence

    first year

  • respiratory morbidity prevalence

    first year

Study Arms (2)

Intervention Group

EXPERIMENTAL

800 IU of Vitamin D once daily

Dietary Supplement: Vitamin D

Control Group

OTHER

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

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_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

Control GroupIntervention Group

Eligibility Criteria

Age33 Weeks - 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

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

Location

Related Publications (1)

  • 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.

    PMID: 33305842DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyBronchiolitisAsthmaPneumoniaPremature Birth

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Inbal Golan Tripto, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatrics pulmonologist

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 31, 2015

Study Start

April 1, 2015

Primary Completion

February 12, 2018

Study Completion

February 12, 2018

Last Updated

February 14, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Locations

IL(1)