Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)

NCT02805907 | Completed Phase 4 Results

• 1 other identifier: 300681
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Number of Asthma Exacerbations

  6 months

• Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)

  6 months

• Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)

  6 months

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Drug: Calcifediol

Control Group (CG)

PLACEBO COMPARATOR

Placebo in a presentation with an identical appearance taken weekly by the oral route

Drug: Placebo

Interventions

Calcifediol DRUG

Intervention Group (IG)

Placebo DRUG

Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical diagnosis of bronchial asthma
• serum 25(OH)D3 levels \< 30 ng/ml.

You may not qualify if:

• 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,
• severe psychosocial problems,
• pregnant
• breast-feeding

Sponsors & Collaborators

• MurciaSalud: lead

Study Sites (1)

Servicio Murciano de Salud

Murcia, Murcia, 30008, Spain

Location

Related Publications (2)

• 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.

  PMID: 24838406 RESULT

• Andujar-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.

  PMID: 33154023 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Calcifediol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Rubén Andújar-Espinosa
• Organization: MurciaSalud

rubemed@hotmail.com

0034669500052

Study Officials

• Rubén Andújar Espinosa, Medicine

  MurciaSalud

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor. Pulmonologist

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 20, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)