The effect of vitamin D supplementation on acute respiratory tract infection in older Australian adults: an analysis of data from the D-Health Trial.

Australia Clinical Trials as Topic Humans Respiratory Tract Infections / drug therapy Treatment Outcome Vitamin D / therapeutic use Vitamin D Deficiency / complications

Journal

The lancet. Diabetes & endocrinology
ISSN: 2213-8595
Titre abrégé: Lancet Diabetes Endocrinol
Pays: England
ID NLM: 101618821

Informations de publication

Date de publication:
02 2021
Historique:
received: 02 09 2020
revised: 28 10 2020
accepted: 29 10 2020
pubmed: 15 1 2021
medline: 16 2 2021
entrez: 14 1 2021
Statut: ppublish

Résumé

Observational studies have linked vitamin D deficiency with acute respiratory tract infection, but results from randomised controlled trials are heterogeneous. We analysed data from the D-Health Trial to determine whether supplementing older Australian adults, recruited from the general population, with monthly doses of vitamin D reduced the risk, duration, and severity of acute respiratory tract infections. We used data from the D-Health Trial, a randomised, double-blind, placebo-controlled trial of monthly vitamin D supplementation, for which acute respiratory infection was a pre-specified trial outcome. Participants were supplemented and followed for up to 5 years. The trial was set within the Australian general population, using the Commonwealth Electoral Roll as the sampling frame, but also allowing some volunteers to participate. Participants were men and women aged 60 to 79 years (with volunteers up to age 84 years). Participants were randomly assigned to receive either vitamin D or placebo (1:1) using computer-generated permuted block randomisation, which was stratified by age, sex, and state. This was an automated process and the assignment list was not visible to study staff or investigators. Active and placebo gel capsules, identical in appearance to ensure masking, were labelled A and B and the code was not available to study staff or investigators. Participants were asked to report occurrence of acute respiratory symptoms over the previous month via annual surveys, and a subset of participants completed 8-week respiratory symptom diaries in winter. As part of our process to maintain blinding, a random sample of participants was selected for analysis of survey data and a separate sample selected for analysis of diary data. Blood samples were obtained from a random sample of participants (about 450 per group per year) and serum 25-hydroxy vitamin D (25[OH]D) concentrations were measured to monitor adherence. We used regression models to estimate odds ratios (OR), rate ratios, and rate differences. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000743763. Between Jan 13, 2014, and May 26, 2015, 421 207 invitations were sent, 40 824 people were interested in participating, and 21 315 participants were recruited and randomised. Of the 16 000 participants selected for potential analysis of survey data, 15 373 were included in the analysis; 295 in the vitamin D group and 332 in the placebo group who were missing data for all five annual surveys were excluded from the analysis. Of the 3800 selected for potential analysis of diary data, 3070 were invited to complete the diaries because 730 had already withdrawn. 2598 people were included in the analysis; 218 people in the vitamin D group and 254 in the placebo group were missing data and were therefore excluded from the analysis. In blood samples collected from randomly sampled participants throughout the trial, the mean serum 25(OH)D concentration was 114·8 (SD 30·3) nmol/L in the vitamin D group and 77·5 (25·2) nmol/L in the placebo group. Vitamin D supplementation did not reduce the risk of acute respiratory tract infection (survey OR 0·98, 95% CI 0·93 to 1·02; diary OR 0·98, 0·83 to 1·15). Analyses of diary data showed reductions in the overall duration of symptoms and of severe symptoms, but these were small and unlikely to be clinically significant. Monthly bolus doses of 60 000 IU of vitamin D did not reduce the overall risk of acute respiratory tract infection, but could slightly reduce the duration of symptoms in the general population. These findings suggest that routine vitamin D supplementation of a population that is largely vitamin D replete is unlikely to have a clinically relevant effect on acute respiratory tract infection. National Health and Medical Research Council.

Sections du résumé

BACKGROUND
Observational studies have linked vitamin D deficiency with acute respiratory tract infection, but results from randomised controlled trials are heterogeneous. We analysed data from the D-Health Trial to determine whether supplementing older Australian adults, recruited from the general population, with monthly doses of vitamin D reduced the risk, duration, and severity of acute respiratory tract infections.
METHODS
We used data from the D-Health Trial, a randomised, double-blind, placebo-controlled trial of monthly vitamin D supplementation, for which acute respiratory infection was a pre-specified trial outcome. Participants were supplemented and followed for up to 5 years. The trial was set within the Australian general population, using the Commonwealth Electoral Roll as the sampling frame, but also allowing some volunteers to participate. Participants were men and women aged 60 to 79 years (with volunteers up to age 84 years). Participants were randomly assigned to receive either vitamin D or placebo (1:1) using computer-generated permuted block randomisation, which was stratified by age, sex, and state. This was an automated process and the assignment list was not visible to study staff or investigators. Active and placebo gel capsules, identical in appearance to ensure masking, were labelled A and B and the code was not available to study staff or investigators. Participants were asked to report occurrence of acute respiratory symptoms over the previous month via annual surveys, and a subset of participants completed 8-week respiratory symptom diaries in winter. As part of our process to maintain blinding, a random sample of participants was selected for analysis of survey data and a separate sample selected for analysis of diary data. Blood samples were obtained from a random sample of participants (about 450 per group per year) and serum 25-hydroxy vitamin D (25[OH]D) concentrations were measured to monitor adherence. We used regression models to estimate odds ratios (OR), rate ratios, and rate differences. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000743763.
FINDINGS
Between Jan 13, 2014, and May 26, 2015, 421 207 invitations were sent, 40 824 people were interested in participating, and 21 315 participants were recruited and randomised. Of the 16 000 participants selected for potential analysis of survey data, 15 373 were included in the analysis; 295 in the vitamin D group and 332 in the placebo group who were missing data for all five annual surveys were excluded from the analysis. Of the 3800 selected for potential analysis of diary data, 3070 were invited to complete the diaries because 730 had already withdrawn. 2598 people were included in the analysis; 218 people in the vitamin D group and 254 in the placebo group were missing data and were therefore excluded from the analysis. In blood samples collected from randomly sampled participants throughout the trial, the mean serum 25(OH)D concentration was 114·8 (SD 30·3) nmol/L in the vitamin D group and 77·5 (25·2) nmol/L in the placebo group. Vitamin D supplementation did not reduce the risk of acute respiratory tract infection (survey OR 0·98, 95% CI 0·93 to 1·02; diary OR 0·98, 0·83 to 1·15). Analyses of diary data showed reductions in the overall duration of symptoms and of severe symptoms, but these were small and unlikely to be clinically significant.
INTERPRETATION
Monthly bolus doses of 60 000 IU of vitamin D did not reduce the overall risk of acute respiratory tract infection, but could slightly reduce the duration of symptoms in the general population. These findings suggest that routine vitamin D supplementation of a population that is largely vitamin D replete is unlikely to have a clinically relevant effect on acute respiratory tract infection.
FUNDING
National Health and Medical Research Council.

Identifiants

DOI: 10.1016/S2213-8587(20)30380-6 PMID: 33444565
pubmed: 33444565
pii: S2213-8587(20)30380-6
doi: 10.1016/S2213-8587(20)30380-6
pii:
doi:

Substances chimiques

Vitamin D 1406-16-2

Banques de données

ANZCTR
['ACTRN12613000743763']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

69-81

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2021 Elsevier Ltd. All rights reserved.

Auteurs

Hai Pham (H)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; School of Public Health, the University of Queensland, Brisbane, QLD, Australia.

Mary Waterhouse (M)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.

Catherine Baxter (C)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.

Briony Duarte Romero (B)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.

Donald S A McLeod (DSA)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; Department of Endocrinology and Diabetes, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.

Bruce K Armstrong (BK)

School of Public Health, University of Sydney, Sydney, NSW, Australia.

Peter R Ebeling (PR)

Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.

Dallas R English (DR)

Melbourne School of Population Health, University of Melbourne, Melbourne, VIC, Australia; Cancer Epidemiology Division, Cancer Council Victoria, Melbourne, VIC, Australia.

Gunter Hartel (G)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.

Michael G Kimlin (MG)

School of Biomedical Sciences, Queensland University of Technology, Brisbane, QLD, Australia.

Adrian R Martineau (AR)

Institute for Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

Rachel O'Connell (R)

NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.

Jolieke C van der Pols (JC)

Faculty of Health, School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, QLD, Australia.

Alison J Venn (AJ)

Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.

Penelope M Webb (PM)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; School of Public Health, the University of Queensland, Brisbane, QLD, Australia.

David C Whiteman (DC)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.

Rachel E Neale (RE)

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia; School of Public Health, the University of Queensland, Brisbane, QLD, Australia. Electronic address: rachel.neale@qimrberghofer.edu.au.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female

Evaluation of Low-Value Services Across Major Medicare Advantage Insurers and Traditional Medicare.

Ciara Duggan, Adam L Beckman, Ishani Ganguli et al.
1.00
Humans United States Aged Cross-Sectional Studies Medicare Part C

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

Hallie Tankha, Devyn Gaskins, Amanda Shallcross et al.
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH

questionsmedicales.fr › Régions géographiques › Océanie › Australasie › Australie › The effect of vitamin D supplementation on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › The effect of vitamin D supplementation on...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › The effect of vitamin D supplementation on...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › The effect of vitamin D supplementation on...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › The effect of vitamin D supplementation on...
questionsmedicales.fr › Composés polycycliques › Composés à cycles fusionnés › Stéroïdes › Sécostéroïdes › Vitamine D › The effect of vitamin D supplementation on...
questionsmedicales.fr › Maladies métaboliques et nutritionnelles › Troubles nutritionnels › Malnutrition › Maladies de carence › Avitaminoses › Carence en vitamine D › The effect of vitamin D supplementation on...