Asthmatic CrisisOPTIVITNCT02880930
Optimizing Vitamin D Status in Children With Wheeze / Asthma (OPTIVIT)
A study testing Fultium-D3 drops (Internis) in people with Asthmatic Crisis and Wheezing, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Asthmatic Crisis, Wheezing
- What is being tested?
- Fultium-D3 drops (Internis)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Vitamin D Status in Children With Pre-school Wheeze or Asthma:a Pilot Study (OPTIVIT)
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.
Read the detailed description
The study is designed to compare the efficacy of a daily oral vitamin D3 supplementation dose of 10 micrograms (400 IU) for 3 months vs a daily oral vitamin D3 supplementation dose of 25 micrograms (1,000 IU) for an additional 3 months in correcting vitamin D deficiency in children with asthma or preschool wheezing illness.
Identification procedures
A member of the patient's usual care team will identify potentially eligible participants from patient records at participating sites. Identified individuals will be contacted by post, giving a brief explanation of the study and asking them to contact a member of the research team if they wish to find out more. A member of the research team will explain the study to them and ask them if they would like to receive the study participant information sheet (PIS). The PIS will be posted to patients expressing an interest in the study; those who subsequently confirm their interest in participation will be re-contacted by the study team, and offered a screening appointment at a study site. Additionally, posters advertising the study and providing contact details for the study team will be displayed in appropriate public places, such as hospital out-patient departments and General Practitioner (GP) surgeries, where potentially eligible participants are likely to see them; advertisements for the study may also be placed in the press, and circulated on email within Queen Mary, University of London. Potentially eligible children who fulfill eligibility criteria and give their assent (if aged ≥7 years) and have consent from their parent/legal guardian will be enrolled in the study.
Study visits
Visit 1 - Screening:
Once the child and their parent/legal guardian decide to take part in the study and sign the agreement forms (assent and consent form), the investigators will record details of children's sociodemographic status, ethnicity, age and sex. The investigators will measure children's body weight and height, and ask children aged >= 5 years to fill in a questionnaire to assess their level of asthma symptom control. The investigators will then collect a drop of each child's blood with a finger-prick to measure his/her vitamin D level and a sample of fluid from one nostril of each child with a small (5 x 25 mm) strip of absorbent material to measure his/her inflammatory status. The investigators will apply a numbing cream or spray to each child's finger before the fingerprick to minimise discomfort.
Telephone contact T1:
The investigators will telephone children's parents/legal guardians to let them know the results of their child's baseline vitamin D test. If this is normal (75 nmol/L or more), then the child does not need a vitamin D supplement: the parent / guardian will be reassured, and the child will not be able to take part in this study. If the level is low, then the investigators will arrange to meet with the child and his/her parent/guardian a second time.
Visit 2 - (1 week later):
At this visit, the investigators will show children's parents/legal guardians how to give their child the study drops each day and also supply them with a bottle of vitamin D drops for their child to take every day at a dose of 6 drops (400 IU; 10 μg) per day. The investigators will also give them a diary where they can record the doses their child takes every day and note down details of unplanned visits to a doctor/nurse due to wheezing illness or worsening of asthma symptoms during the study.
Telephone contact T2 - (One week after Visit 2):
The investigators will telephone parents/legal guardians as arranged to check if their child is taking the study drops and to see how they are getting on. The investigators will also check if their child has made any unplanned visits to a doctor or a nurse due to wheezing illness or worsening of asthma symptoms since the last study visit.
Telephone contact T3 - (Three weeks after telephone call T2):
In this telephone call, the investigators will make the same checks as those in telephone contact T2.
Visit 3 - (Month 3):
In this visit, the investigators will perform the same tests as those in study visit 1. The investigators will take back the bottle with the remaining vitamin D liquid and the completed study diary, and provide a new diary and bottle with study drops.
Telephone contact T4 - (One week after Visit 3):
In this telephone call, the investigators will do the same checks as those in telephone call T2. The investigators will also let parents/legal guardians know results of their child's second vitamin D test. Based on this result, the investigators will decide if their child needs to increase the dose to 15 drops (1,000 IU; 25 μg) per day for a further 3 months or to continue with 6 drops (400 IU; 10 μg) per day for a further 3 months or to stop vitamin D supplementation.
Telephone contact T5 - (Three weeks after telephone call T4):
In this telephone call, the investigators will make the same checks as those in telephone contact T2.
Visit 4 - FINAL VISIT - (Month 6):
In this study visit, the investigators will perform the same tests as those in study visit 1. The investigators will ask parents/legal guardians to complete a final questionnaire about their child's experience in the study. The investigators will take back the bottle with the remaining study drops and the completed study diary. Once enrolment to the study and analysis of all study data is complete, the investigators will write to participants' parents/legal guardians to tell them about our final findings, including results of their child's final vitamin D test.
Additional procedures throughout the study:
Participants' parents/legal guardians will be asked to report the daily supplementation doses their child takes and record details of unplanned healthcare visits to a GP/nurse due to wheezing illness or worsening of asthma symptoms during the study.
If a participant reports symptoms of raised blood calcium level during the study nausea, vomiting or feeling generally unwell), an urgent check of his/her corrected blood calcium level will be performed and an appointment with a pediatrician will be arranged if necessary.
- Conditions
- Asthmatic Crisis, Wheezing
- Being tested
- Fultium-D3 drops (Internis)
- Keywords
- vitamin D
- Medical subject headings
- Status Asthmaticus, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Fultium-D3 drops (Internis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
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
Measured: 6 months in total
Changes from baseline in childhood Asthma Control Test at 3 and 6 months
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.
Measured: 6 months in total
Adherence to study supplement
To determine the proportion of vitamin D3 supplementation doses taken (self-reported and supplement volume assessment) during the study
Measured: 6 months in total
Capture of unscheduled health care attendances for asthma or wheezing illness (self-reported)
To define the number of unscheduled healthcare attendances for asthma exacerbation(s) or wheezing illness as self-reported by individuals and their parents.
Measured: 6 months in total
Capture of unscheduled health care attendances for asthma or wheezing illness
To define the number of unscheduled healthcare attendances for asthma exacerbation(s) or wheezing illness as reported by GP records
Measured: 6 months in total
Agreement between self-reported and GP record number of unscheduled healthcare visits
To evaluate agreement between self-reported and GP record number of unscheduled healthcare attendance for wheezing illness or asthma exacerbation(s).
Measured: 6 months in total
Determinants of vitamin D status
To identify determinants of increase in serum 25(OH)D concentration in response to daily oral vitamin D3 supplementation
Measured: 6 months in total
Participant's feedback about the study
To evaluate children's and parents' experiences of taking part in the study (qualitative evaluation).
Measured: 6 months in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthmatic CrisisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Martineau, Principal investigator, Barts and The London School of Medicine and Dentistry, Queen Mary University, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880930
- Sponsor's protocol ID
- 011320
- Acronym
- OPTIVIT
- Status last verified
- Apr 2018
- First submitted
- 5 Aug 2016
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Vitamin D Status in Children With Pre-school Wheeze or Asthma:a Pilot Study (OPTIVIT)
- ClinicalTrials.gov ID
- NCT02880930
- Acronym / sponsor ID
- OPTIVIT / 011320
- Conditions
- Asthmatic Crisis, Wheezing
- Keywords
- vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is designed to compare the efficacy of a daily oral vitamin D3 supplementation dose of 10 micrograms (400 IU) for 3 months vs a daily oral vitamin D3 supplementation dose of 25 micrograms (1,000 IU) for an additional 3 months in correcting vitamin D deficiency in children with asthma or preschool wheezing illness.
Identification procedures
A member of the patient's usual care team will identify potentially eligible participants from patient records at participating sites. Identified individuals will be contacted by post, giving a brief explanation of the study and asking them to contact a member of the research team if they wish to find out more. A member of the research team will explain the study to them and ask them if they would like to receive the study participant information sheet (PIS). The PIS will be posted to patients expressing an interest in the study; those who subsequently confirm their interest in participation will be re-contacted by the study team, and offered a screening appointment at a study site. Additionally, posters advertising the study and providing contact details for the study team will be displayed in appropriate public places, such as hospital out-patient departments and General Practitioner (GP) surgeries, where potentially eligible participants are likely to see them; advertisements for the study may also be placed in the press, and circulated on email within Queen Mary, University of London. Potentially eligible children who fulfill eligibility criteria and give their assent (if aged ≥7 years) and have consent from their parent/legal guardian will be enrolled in the study.
Study visits
Visit 1 - Screening:
Once the child and their parent/legal guardian decide to take part in the study and sign the agreement forms (assent and consent form), the investigators will record details of children's sociodemographic status, ethnicity, age and sex. The investigators will measure children's body weight and height, and ask children aged >= 5 years to fill in a questionnaire to assess their level of asthma symptom control. The investigators will then collect a drop of each child's blood with a finger-prick to measure his/her vitamin D level and a sample of fluid from one nostril of each child with a small (5 x 25 mm) strip of absorbent material to measure his/her inflammatory status. The investigators will apply a numbing cream or spray to each child's finger before the fingerprick to minimise discomfort.
Telephone contact T1:
The investigators will telephone children's parents/legal guardians to let them know the results of their child's baseline vitamin D test. If this is normal (75 nmol/L or more), then the child does not need a vitamin D supplement: the parent / guardian will be reassured, and the child will not be able to take part in this study. If the level is low, then the investigators will arrange to meet with the child and his/her parent/guardian a second time.
Visit 2 - (1 week later):
At this visit, the investigators will show children's parents/legal guardians how to give their child the study drops each day and also supply them with a bottle of vitamin D drops for their child to take every day at a dose of 6 drops (400 IU; 10 μg) per day. The investigators will also give them a diary where they can record the doses their child takes every day and note down details of unplanned visits to a doctor/nurse due to wheezing illness or worsening of asthma symptoms during the study.
Telephone contact T2 - (One week after Visit 2):
The investigators will telephone parents/legal guardians as arranged to check if their child is taking the study drops and to see how they are getting on. The investigators will also check if their child has made any unplanned visits to a doctor or a nurse due to wheezing illness or worsening of asthma symptoms since the last study visit.
Telephone contact T3 - (Three weeks after telephone call T2):
In this telephone call, the investigators will make the same checks as those in telephone contact T2.
Visit 3 - (Month 3):
In this visit, the investigators will perform the same tests as those in study visit 1. The investigators will take back the bottle with the remaining vitamin D liquid and the completed study diary, and provide a new diary and bottle with study drops.
Telephone contact T4 - (One week after Visit 3):
In this telephone call, the investigators will do the same checks as those in telephone call T2. The investigators will also let parents/legal guardians know results of their child's second vitamin D test. Based on this result, the investigators will decide if their child needs to increase the dose to 15 drops (1,000 IU; 25 μg) per day for a further 3 months or to continue with 6 drops (400 IU; 10 μg) per day for a further 3 months or to stop vitamin D supplementation.
Telephone contact T5 - (Three weeks after telephone call T4):
In this telephone call, the investigators will make the same checks as those in telephone contact T2.
Visit 4 - FINAL VISIT - (Month 6):
In this study visit, the investigators will perform the same tests as those in study visit 1. The investigators will ask parents/legal guardians to complete a final questionnaire about their child's experience in the study. The investigators will take back the bottle with the remaining study drops and the completed study diary. Once enrolment to the study and analysis of all study data is complete, the investigators will write to participants' parents/legal guardians to tell them about our final findings, including results of their child's final vitamin D test.
Additional procedures throughout the study:
Participants' parents/legal guardians will be asked to report the daily supplementation doses their child takes and record details of unplanned healthcare visits to a GP/nurse due to wheezing illness or worsening of asthma symptoms during the study.
If a participant reports symptoms of raised blood calcium level during the study nausea, vomiting or feeling generally unwell), an urgent check of his/her corrected blood calcium level will be performed and an appointment with a pediatrician will be arranged if necessary.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplement (Cholecalciferol) | Experimental | Dietary Supplement: Fultium-D3 drops (Internis)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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 1-12 years
- Children's parent/legal guardian gives informed consent for children.
- If child aged ≥7 years, gives informed assent.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fultium-D3 drops (Internis)Oral daily doses of vitamin D3 (400 IU for 3 months; and 1,000 IU for an additional 3 months) | Dietary supplement | Vitamin D supplement (Cholecalciferol) |
Primary outcome
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
9 secondary outcomes
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
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
Changes from baseline in childhood Asthma Control Test at 3 and 6 months
Time frame: 6 months in total
Adherence to study supplement
Time frame: 6 months in total
Capture of unscheduled health care attendances for asthma or wheezing illness (self-reported)
Time frame: 6 months in total
Capture of unscheduled health care attendances for asthma or wheezing illness
Time frame: 6 months in total
Agreement between self-reported and GP record number of unscheduled healthcare visits
Time frame: 6 months in total
Determinants of vitamin D status
Time frame: 6 months in total
Participant's feedback about the study
Time frame: 6 months in total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Martineau principal investigator
Barts and The London School of Medicine and Dentistry, Queen Mary University, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fultium-D3 drops (Internis) in people with Asthmatic Crisis and Wheezing, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.