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

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ClinicalTrials.gov Identifier: NCT02880930
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

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.

Condition or disease Intervention/treatment Phase
Asthmatic Crisis Wheezing Dietary Supplement: Fultium-D3 drops (Internis) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing Vitamin D Status in Children With Pre-school Wheeze or Asthma:a Pilot Study (OPTIVIT)
Study Start Date : December 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D supplement (Cholecalciferol)
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)
Oral daily doses of vitamin D3 (400 IU for 3 months; and 1,000 IU for an additional 3 months)




Primary Outcome Measures :
  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 [ Time Frame: 6 months in total ]
    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


Secondary Outcome Measures :
  1. Proportion of children with treatment related adverse events D status at 3 and 6 months of oral vitamin D3 supplementation [ Time Frame: 6 months in total ]
    To define the proportion of individuals with 25(OH)D concentration above 220nmol/L at 3 and 6 months after daily oral vitamin D3 supplementation.

  2. Changes from baseline in concentration of inflammatory mediators in nasal epithelial lining fluid at 3 and 6 months after daily oral vitamin D3 supplementation [ Time Frame: 6 months in total ]
    To determine the effect of different regimens of oral vitamin D supplementation on concentrations of inflammatory mediators in nasal epithelial lining fluid (ELF) at 3 and 6 months

  3. Changes from baseline in childhood Asthma Control Test at 3 and 6 months [ Time Frame: 6 months in total ]
    To determine the difference in childhood asthma control test score (c-ACT) at 3 months vs. 0 months and 6 months vs. 0 months for children ≥5 years.

  4. Adherence to study supplement [ Time Frame: 6 months in total ]
    To determine the proportion of vitamin D3 supplementation doses taken (self-reported and supplement volume assessment) during the study

  5. Capture of unscheduled health care attendances for asthma or wheezing illness (self-reported) [ Time Frame: 6 months in total ]
    To define the number of unscheduled healthcare attendances for asthma exacerbation(s) or wheezing illness as self-reported by individuals and their parents.

  6. Capture of unscheduled health care attendances for asthma or wheezing illness [ Time Frame: 6 months in total ]
    To define the number of unscheduled healthcare attendances for asthma exacerbation(s) or wheezing illness as reported by GP records

  7. Agreement between self-reported and GP record number of unscheduled healthcare visits [ Time Frame: 6 months in total ]
    To evaluate agreement between self-reported and GP record number of unscheduled healthcare attendance for wheezing illness or asthma exacerbation(s).

  8. Determinants of vitamin D status [ Time Frame: 6 months in total ]
    To identify determinants of increase in serum 25(OH)D concentration in response to daily oral vitamin D3 supplementation

  9. Participant's feedback about the study [ Time Frame: 6 months in total ]
    To evaluate children's and parents' experiences of taking part in the study (qualitative evaluation).



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880930


Locations
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United Kingdom
The Royal London Hospital
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Queen Mary University of London
Investigators
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Principal Investigator: Adrian Martineau Barts and The London School of Medicine and Dentistry, Queen Mary University, University of London

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02880930     History of Changes
Other Study ID Numbers: 011320
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Queen Mary University of London:
vitamin D

Additional relevant MeSH terms:
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Respiratory Sounds
Status Asthmaticus
Signs and Symptoms, Respiratory
Signs and Symptoms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents