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Health Condition(s) or Problem
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Asthma
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Lay Summary
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The study null hypothesis is that vitamin D supplementation will not influence time to upper
respiratory tract infection or time to severe asthma exacerbation in adult and adolescent
patients with asthma.
(from ClinicalTrials.gov)
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Who can enter the trial
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Principal Inclusion Criteria:
- Medical record diagnosis of asthma
- Age = 16 years and = 80 years on day of first dose of IMP
- If a woman of child-bearing potential, is sexually abstinent or has negative
pregnancy test within 7 days of recruitment and agrees to use reliable form of
contraception until she has completed the study
- Able to give written informed consent to participate in the study
Principal Exclusion Criteria:
- Diagnosis of COPD
- Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin
D intolerance, liver failure, renal failure, terminal illness, lymphoma or other
malignancy not in remission for = 3 years
- Any other condition that, in an investigator's judgement, might compromise patient
safety or compliance, interfere with evaluation or preclude completion of the study
- Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital,
phenytoin or primidone
- Taking dietary supplement containing vitamin D up to 2 months before first dose of
IMP
- Treatment with any investigational medical product or device up to 4 months before
first dose of IMP
- Breastfeeding, pregnant or planning a pregnancy
- Baseline corrected serum calcium > 2.65 mmol/L
- Baseline serum creatinine > 125 micromol/L
- Smoking history >15 pack-years
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Who cannot enter the trial
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Principal Inclusion Criteria:
- Medical record diagnosis of asthma
- Age = 16 years and = 80 years on day of first dose of IMP
- If a woman of child-bearing potential, is sexually abstinent or has negative
pregnancy test within 7 days of recruitment and agrees to use reliable form of
contraception until she has completed the study
- Able to give written informed consent to participate in the study
Principal Exclusion Criteria:
- Diagnosis of COPD
- Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin
D intolerance, liver failure, renal failure, terminal illness, lymphoma or other
malignancy not in remission for = 3 years
- Any other condition that, in an investigator's judgement, might compromise patient
safety or compliance, interfere with evaluation or preclude completion of the study
- Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital,
phenytoin or primidone
- Taking dietary supplement containing vitamin D up to 2 months before first dose of
IMP
- Treatment with any investigational medical product or device up to 4 months before
first dose of IMP
- Breastfeeding, pregnant or planning a pregnancy
- Baseline corrected serum calcium > 2.65 mmol/L
- Baseline serum creatinine > 125 micromol/L
- Smoking history >15 pack-years
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What will happen
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Dietary Supplement; Cholecalciferol; Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year; Vigantol oil; Dietary Supplement; Miglyol oil; Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year; Miglyol oil
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Primary aim
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Time to first upper respiratory tract infection; Time to first severe asthma exacerbation
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Secondary Aim
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Asthma Control Test Score; One year; No; Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation; One year; No; Proportion of participants experiencing hypercalcaemia; One year; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Not Recruiting
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Nation
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England
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Location
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London
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