Asthma, BronchialPhase 4ACViDNCT02805907
Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
A Phase 4 study testing Calcifediol in people with Asthma, Bronchial, run by MurciaSalud at 1 site in Spain.
Trial summary
Introduction: There are many cross-sectional studies in children and adults indicating that low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer lung function, decreased response to glucocorticoids and more frequent exacerbations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Bronchial
- What is being tested?
- Calcifediol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Jan 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical diagnosis of bronchial asthma
- serum 25(OH)D3 levels < 30 ng/ml.
Who cannot join
- smoking habit ≥ 10 pack-years,
- taking vitamin D supplements,
- kidney disease (creat. > 2 mg/dl),
- hypercalcaemia (corrected with proteins > 10.5 mg/dl),
- repeat episodes of renal colic,
- any gastrointestinal disease that might interfere with vitamin D absorption,
Show all 9Show fewer
- severe psychosocial problems,
- pregnant
- breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: There are many cross-sectional studies in children and adults indicating that low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer lung function, decreased response to glucocorticoids and more frequent exacerbations. Moreover, as there is a significant group of asthmatic patients having insufficient control of their disease, despite high doses of inhaled corticosteroids, we have investigated new treatment alternatives, which include vitamin
Objective: To determine the efficacy of vitamin D supplementation in asthmatic patients with vitamin D deficiency in degree of asthma control.
Materials and methods: A prospective, controlled, randomised, triple-blind study was conducted with a follow-up of 6 months. The patients recruited were over 18 years of age with a medical diagnosis of bronchial asthma and serum 25(OH)D3 levels < 30 ng/ml. Patients were excluded if they had a smoking habit ≥ 10 pack-years, taking vitamin D supplements, kidney disease (creat. > 2 mg/dl), hypercalcaemia (corrected with proteins > 10.5 mg/dl), a repeat episodes of renal colic, any gastrointestinal disease that might interfere with vitamin D absorption, or severe psychosocial problems, or were pregnant or breast-feeding. The randomisation process assigned patients to one of two groups: a group that received vitamin D (in the form of calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route) and another group that received placebo in a presentation with an identical appearance and the same administration regimen. Demographic, clinical, spirometry and laboratory endpoints were collected. The primary endpoint was degree of asthma control as determined by the internationally validated Asthma Control Test (ACT). The secondary endpoints were asthma exacerbations, dose of inhaled corticosteroids and quality of life as measured using the Mini-AQLQ (Asthma Quality of Life Questionnaire).
- Conditions
- Asthma, Bronchial
- Being tested
- Calcifediol, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcifediolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG) | Experimental | Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Receives: Drug: Calcifediol |
| Control Group (CG) | Placebo comparator | Placebo in a presentation with an identical appearance taken weekly by the oral route Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Measured With Asthma Control Test (ACT)
Asthma Control Test (ACT): Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.
Measured: 6 months
Secondary outcomes (3)
Number of Asthma Exacerbations
Number of asthma exacerbations during the study period
Measured: 6 months
Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)
Dose inhaled corticosteroids as the scale of the Spanish guide for asthma management (GEMA 4.0): Depends on the type of steroids:
Beclomethasone dipropionate (Low dose: 200-500 mcg/day, Half dose: 501-1000 mcg/day, High dose: 1001-2000 mcg/day), Beclomethasone extrafine (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: > 400 mcg/day), Budesonide (Low dose: 200-400 mcg/day, Half dose: 401-800 mcg/day, High dose: 801-1600 mcg/day), Ciclesonide (Low dose: 80-160 mcg/day, Half dose: 161-320 mcg/day, High dose: 321-1280 mcg/day), Fluticasone furoate (Half dose: 92 mcg/day, High dose: 184 mcg/day), Fluticasone propionate (Low dose: 100-250 mcg/day, Half dose: 251-500 mcg/day, High dose: 501-1000 mcg/day), Mometasone furoate (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: 401-800 mcg/day),
Measured: 6 months
Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)
Mini-AQLQ (Asthma Quality of Life Questionnaire): The response options for each item are placed on an equidistant 7-point scale, where 1 = maximum limitation and 7 = no limitation. The questionnaire Global score, which is the mean for all 15 items that make up the scale, and a score for each dimension, which is the average of the corresponding items for that dimension.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma, BronchialStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- MurciaSalud
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rubén Andújar, MurciaSalud
- Investigators
- Rubén Andújar Espinosa, Medicine, Principal investigator, MurciaSalud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805907
- Sponsor's protocol ID
- 300681
- Acronym
- ACViD
- Status last verified
- Apr 2017
- First submitted
- 13 Jun 2016
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Castro M, King TS, Kunselman SJ, Cabana MD, Denlinger L, Holguin F, Kazani SD, Moore WC, Moy J, Sorkness CA, Avila P, Bacharier LB, Bleecker E, Boushey HA, Chmiel J, Fitzpatrick AM, Gentile D, Hundal M, Israel E, Kraft M, Krishnan JA, LaForce C, Lazarus SC, Lemanske R, Lugogo N, Martin RJ, Mauger DT, Naureckas E, Peters SP, Phipatanakul W, Que LG, Sheshadri A, Smith L, Solway J, Sullivan-Vedder L, Sumino K, Wechsler ME, Wenzel S, White SR, Sutherland ER; National Heart, Lung, and Blood Institute's AsthmaNet. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.
PubMed 24838406Andujar-Espinosa R, Salinero-Gonzalez L, Illan-Gomez F, Castilla-Martinez M, Hu-Yang C, Ruiz-Lopez FJ. Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial. Thorax. 2021 Feb;76(2):126-133. doi: 10.1136/thoraxjnl-2019-213936. Epub 2020 Nov 5.
PubMed 33154023
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
- ClinicalTrials.gov ID
- NCT02805907
- Acronym / sponsor ID
- ACViD / 300681
- Conditions
- Asthma, Bronchial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- MurciaSaludOther government
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: There are many cross-sectional studies in children and adults indicating that low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer lung function, decreased response to glucocorticoids and more frequent exacerbations. Moreover, as there is a significant group of asthmatic patients having insufficient control of their disease, despite high doses of inhaled corticosteroids, we have investigated new treatment alternatives, which include vitamin
Objective: To determine the efficacy of vitamin D supplementation in asthmatic patients with vitamin D deficiency in degree of asthma control.
Materials and methods: A prospective, controlled, randomised, triple-blind study was conducted with a follow-up of 6 months. The patients recruited were over 18 years of age with a medical diagnosis of bronchial asthma and serum 25(OH)D3 levels < 30 ng/ml. Patients were excluded if they had a smoking habit ≥ 10 pack-years, taking vitamin D supplements, kidney disease (creat. > 2 mg/dl), hypercalcaemia (corrected with proteins > 10.5 mg/dl), a repeat episodes of renal colic, any gastrointestinal disease that might interfere with vitamin D absorption, or severe psychosocial problems, or were pregnant or breast-feeding. The randomisation process assigned patients to one of two groups: a group that received vitamin D (in the form of calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route) and another group that received placebo in a presentation with an identical appearance and the same administration regimen. Demographic, clinical, spirometry and laboratory endpoints were collected. The primary endpoint was degree of asthma control as determined by the internationally validated Asthma Control Test (ACT). The secondary endpoints were asthma exacerbations, dose of inhaled corticosteroids and quality of life as measured using the Mini-AQLQ (Asthma Quality of Life Questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Drug: CalcifediolCalcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route |
| Control Group (CG) | Placebo comparator | Drug: PlaceboPlacebo in a presentation with an identical appearance taken weekly by the oral route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medical diagnosis of bronchial asthma
- serum 25(OH)D3 levels < 30 ng/ml.
Key exclusion criteria (9 listed)
- smoking habit ≥ 10 pack-years,
- taking vitamin D supplements,
- kidney disease (creat. > 2 mg/dl),
- hypercalcaemia (corrected with proteins > 10.5 mg/dl),
- repeat episodes of renal colic,
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 |
|---|---|---|
| Calcifediol | Drug | Intervention Group (IG) |
| Placebo | Drug | Control Group (CG) |
Primary outcome
Asthma Control Measured With Asthma Control Test (ACT)
Time frame: 6 months
Asthma Control Test (ACT): Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.
3 secondary outcomes
Number of Asthma Exacerbations
Time frame: 6 months
Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)
Time frame: 6 months
Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24838406Castro M, King TS, Kunselman SJ, Cabana MD, Denlinger L, Holguin F, Kazani SD, Moore WC, Moy J, Sorkness CA, Avila P, Bacharier LB, Bleecker E, Boushey HA, Chmiel J, Fitzpatrick AM, Gentile D, Hundal M, Israel E, Kraft M, Krishnan JA, LaForce C, Lazarus SC, Lemanske R, Lugogo N, Martin RJ, Mauger DT, Naureckas E, Peters SP, Phipatanakul W, Que LG, Sheshadri A, Smith L, Solway J, Sullivan-Vedder L, Sumino K, Wechsler ME, Wenzel S, White SR, Sutherland ER; National Heart, Lung, and Blood Institute's AsthmaNet. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.
- Derived from this study: PubMed 33154023Andujar-Espinosa R, Salinero-Gonzalez L, Illan-Gomez F, Castilla-Martinez M, Hu-Yang C, Ruiz-Lopez FJ. Effect of vitamin D supplementation on asthma control in patients with vitamin D deficiency: the ACVID randomised clinical trial. Thorax. 2021 Feb;76(2):126-133. doi: 10.1136/thoraxjnl-2019-213936. Epub 2020 Nov 5.
- Individual participant dataSharing planned: No
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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.
Rubén Andújar Espinosa, Medicine principal investigator
MurciaSalud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcifediol in people with Asthma, Bronchial, run by MurciaSalud at 1 site in Spain.
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 2 inclusion and 9 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 16 Jun 2017. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Asthma Control Measured With Asthma Control Test (ACT) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805907, which also lists 2 linked publications.
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 16 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.