Optimizing Vitamin D Status in Children With Wheeze / Asthma (OPTIVIT)

NCT02880930 | Completed

• 1 other identifier: 011320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D deficiency is highly prevalent in the UK. Research shows that vitamin D enhances the immune system and may help protect against chest infections that can cause wheezing illness or worsen asthma symptoms. The Department of Health recommends a dose of 10 micrograms of vitamin D/day to prevent severe vitamin D deficiency in children. However, many studies have reported that this dose is not enough to raise plasma 25(OH)D concentration to the levels most likely to prevent against worsening of asthma symptoms. Such studies suggest that 25 micrograms of vitamin D/day. This dose is safe but its effects on vitamin D blood levels have not yet been specifically tested in children with asthma/wheeze. This study is designed to determine the optimal oral daily vitamin D supplementation dose to treat vitamin D deficiency in children with asthma or preschool wheeze. Over the 6-month course of the study, participants will meet with the study team four times in clinic or in their own home and will be contacted by telephone five times. Children will be asked to give a drop of blood via a fingerprick to test their vitamin D level and a sample of nasal epithelial lining fluid for measurement of inflammatory markers on three separate occasions.

Conditions

Asthmatic Crisis; Wheezing

Keywords

vitamin D

Outcome Measures

Primary Outcomes (1)

• Proportion of children with vitamin D status above or equal to 75 nmol/L at 3 and 6 months of oral vitamin D3 supplementation

  Proportion of children with asthma and pre-school wheezing illness with baseline serum 25(OH)D concentration\<75 nmol/L attaining serum 25(OH)D concentration \>75 nmol/L after 3 months of an oral daily dose of 400 IU and after an additional 3 months of oral daily vitamin D3 supplementation with 1,000 IU

  6 months in total

Secondary Outcomes (9)

• Proportion of children with treatment related adverse events D status at 3 and 6 months of oral vitamin D3 supplementation

  6 months in total

• Changes from baseline in concentration of inflammatory mediators in nasal epithelial lining fluid at 3 and 6 months after daily oral vitamin D3 supplementation

  6 months in total

• Changes from baseline in childhood Asthma Control Test at 3 and 6 months

  6 months in total

• Adherence to study supplement

  6 months in total

• Capture of unscheduled health care attendances for asthma or wheezing illness (self-reported)

  6 months in total

Study Arms (1)

Vitamin D supplement (Cholecalciferol)

EXPERIMENTAL

Participants will be given oral Fultium-D3 drops (Internis) contain 400 IU cholecalciferol/day for a period of 3 months. Daily vitamin D3 supplementation dose will be increased to 1,000 IU for an additional 3 months if plasma 25(OH)D still below 75 nmol/L.

Dietary Supplement: Fultium-D3 drops (Internis)

Interventions

Fultium-D3 drops (Internis) DIETARY_SUPPLEMENT

Oral daily doses of vitamin D3 (400 IU for 3 months; and 1,000 IU for an additional 3 months)

Vitamin D supplement (Cholecalciferol)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1-12 years
• For children aged 1-4 years: ≥2 self-reported wheezing illness episodes (as shown in a video recording of a wheeze episode) requiring unscheduled healthcare in the previous year
• For children aged 5-12 years: doctor diagnosis of asthma and ≥1 self-reported asthma exacerbation requiring an unscheduled healthcare visit in the previous year.
• Children's parent/legal guardian gives informed consent for children.
• If child aged ≥7 years, gives informed assent.

You may not qualify if:

• Baseline 25(OH)D concentration ≥75 nmol/L.
• Already taking any vitamin D supplements.
• Any other chronic or recent acute respiratory or systemic condition.
• Already enrolled in another interventional research study

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Status Asthmaticus; Respiratory Sounds

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Martineau

  Barts and The London School of Medicine and Dentistry, Queen Mary University, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 26, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 8, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)