Vitamin D supplementation to prevent acute respiratory infections: individual participant data meta-analysis
Randomised controlled trials (RCTs) exploring the potential of vitamin D to prevent acute respiratory infections have yielded mixed results. Individual participant data (IPD) meta-analysis has the potential to identify factors that may explain this heterogeneity. To assess the overall effect of vita...
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| Published in | Health technology assessment (Winchester, England) Vol. 23; no. 2; pp. 1 - 44 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
NIHR Journals Library
01.01.2019
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 1366-5278 2046-4924 2046-4924 |
| DOI | 10.3310/hta23020 |
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| Abstract | Randomised controlled trials (RCTs) exploring the potential of vitamin D to prevent acute respiratory infections have yielded mixed results. Individual participant data (IPD) meta-analysis has the potential to identify factors that may explain this heterogeneity.
To assess the overall effect of vitamin D supplementation on the risk of acute respiratory infections (ARIs) and to identify factors modifying this effect.
MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, ClinicalTrials.gov and the International Standard Randomised Controlled Trials Number (ISRCTN) registry.
Randomised, double-blind, placebo-controlled trials of supplementation with vitamin D
or vitamin D
of any duration having incidence of acute respiratory infection as a prespecified efficacy outcome were selected.
Study quality was assessed using the Cochrane Collaboration Risk of Bias tool to assess sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, completeness of outcome data, evidence of selective outcome reporting and other potential threats to validity.
We identified 25 eligible RCTs (a total of 11,321 participants, aged from 0 to 95 years). IPD were obtained for 10,933 out of 11,321 (96.6%) participants. Vitamin D supplementation reduced the risk of ARI among all participants [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.81 to 0.96; heterogeneity
< 0.001]. Subgroup analysis revealed that protective effects were seen in individuals receiving daily or weekly vitamin D without additional bolus doses (aOR 0.81, 95% CI 0.72 to 0.91), but not in those receiving one or more bolus doses (aOR 0.97, 95% CI 0.86 to 1.10;
= 0.05). Among those receiving daily or weekly vitamin D, protective effects of vitamin D were stronger in individuals with a baseline 25-hydroxyvitamin D [25(OH)D] concentration of < 25 nmol/l (aOR 0.30, 95% CI 0.17 to 0.53) than in those with a baseline 25(OH)D concentration of ≥ 25 nmol/l (aOR 0.75, 95% CI 0.60 to 0.95;
= 0.006). Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (aOR 0.98, 95% CI 0.80 to 1.20;
= 0.83). The body of evidence contributing to these analyses was assessed as being of high quality.
Our study had limited power to detect the effects of vitamin D supplementation on the risk of upper versus lower respiratory infection, analysed separately.
Vitamin D supplementation was safe, and it protected against ARIs overall. Very deficient individuals and those not receiving bolus doses experienced the benefit. Incorporation of additional IPD from ongoing trials in the field has the potential to increase statistical power for analyses of secondary outcomes.
This study is registered as PROSPERO CRD42014013953.
The National Institute for Health Research Health Technology Assessment programme. |
|---|---|
| AbstractList | Randomised controlled trials (RCTs) exploring the potential of vitamin D to prevent acute respiratory infections have yielded mixed results. Individual participant data (IPD) meta-analysis has the potential to identify factors that may explain this heterogeneity.
To assess the overall effect of vitamin D supplementation on the risk of acute respiratory infections (ARIs) and to identify factors modifying this effect.
MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, ClinicalTrials.gov and the International Standard Randomised Controlled Trials Number (ISRCTN) registry.
Randomised, double-blind, placebo-controlled trials of supplementation with vitamin D
or vitamin D
of any duration having incidence of acute respiratory infection as a prespecified efficacy outcome were selected.
Study quality was assessed using the Cochrane Collaboration Risk of Bias tool to assess sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, completeness of outcome data, evidence of selective outcome reporting and other potential threats to validity.
We identified 25 eligible RCTs (a total of 11,321 participants, aged from 0 to 95 years). IPD were obtained for 10,933 out of 11,321 (96.6%) participants. Vitamin D supplementation reduced the risk of ARI among all participants [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.81 to 0.96; heterogeneity
< 0.001]. Subgroup analysis revealed that protective effects were seen in individuals receiving daily or weekly vitamin D without additional bolus doses (aOR 0.81, 95% CI 0.72 to 0.91), but not in those receiving one or more bolus doses (aOR 0.97, 95% CI 0.86 to 1.10;
= 0.05). Among those receiving daily or weekly vitamin D, protective effects of vitamin D were stronger in individuals with a baseline 25-hydroxyvitamin D [25(OH)D] concentration of < 25 nmol/l (aOR 0.30, 95% CI 0.17 to 0.53) than in those with a baseline 25(OH)D concentration of ≥ 25 nmol/l (aOR 0.75, 95% CI 0.60 to 0.95;
= 0.006). Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (aOR 0.98, 95% CI 0.80 to 1.20;
= 0.83). The body of evidence contributing to these analyses was assessed as being of high quality.
Our study had limited power to detect the effects of vitamin D supplementation on the risk of upper versus lower respiratory infection, analysed separately.
Vitamin D supplementation was safe, and it protected against ARIs overall. Very deficient individuals and those not receiving bolus doses experienced the benefit. Incorporation of additional IPD from ongoing trials in the field has the potential to increase statistical power for analyses of secondary outcomes.
This study is registered as PROSPERO CRD42014013953.
The National Institute for Health Research Health Technology Assessment programme. Randomised controlled trials (RCTs) exploring the potential of vitamin D to prevent acute respiratory infections have yielded mixed results. Individual participant data (IPD) meta-analysis has the potential to identify factors that may explain this heterogeneity.BACKGROUNDRandomised controlled trials (RCTs) exploring the potential of vitamin D to prevent acute respiratory infections have yielded mixed results. Individual participant data (IPD) meta-analysis has the potential to identify factors that may explain this heterogeneity.To assess the overall effect of vitamin D supplementation on the risk of acute respiratory infections (ARIs) and to identify factors modifying this effect.OBJECTIVESTo assess the overall effect of vitamin D supplementation on the risk of acute respiratory infections (ARIs) and to identify factors modifying this effect.MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, ClinicalTrials.gov and the International Standard Randomised Controlled Trials Number (ISRCTN) registry.DATA SOURCESMEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, ClinicalTrials.gov and the International Standard Randomised Controlled Trials Number (ISRCTN) registry.Randomised, double-blind, placebo-controlled trials of supplementation with vitamin D3 or vitamin D2 of any duration having incidence of acute respiratory infection as a prespecified efficacy outcome were selected.STUDY SELECTIONRandomised, double-blind, placebo-controlled trials of supplementation with vitamin D3 or vitamin D2 of any duration having incidence of acute respiratory infection as a prespecified efficacy outcome were selected.Study quality was assessed using the Cochrane Collaboration Risk of Bias tool to assess sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, completeness of outcome data, evidence of selective outcome reporting and other potential threats to validity.STUDY APPRAISALStudy quality was assessed using the Cochrane Collaboration Risk of Bias tool to assess sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, completeness of outcome data, evidence of selective outcome reporting and other potential threats to validity.We identified 25 eligible RCTs (a total of 11,321 participants, aged from 0 to 95 years). IPD were obtained for 10,933 out of 11,321 (96.6%) participants. Vitamin D supplementation reduced the risk of ARI among all participants [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.81 to 0.96; heterogeneity p < 0.001]. Subgroup analysis revealed that protective effects were seen in individuals receiving daily or weekly vitamin D without additional bolus doses (aOR 0.81, 95% CI 0.72 to 0.91), but not in those receiving one or more bolus doses (aOR 0.97, 95% CI 0.86 to 1.10; p = 0.05). Among those receiving daily or weekly vitamin D, protective effects of vitamin D were stronger in individuals with a baseline 25-hydroxyvitamin D [25(OH)D] concentration of < 25 nmol/l (aOR 0.30, 95% CI 0.17 to 0.53) than in those with a baseline 25(OH)D concentration of ≥ 25 nmol/l (aOR 0.75, 95% CI 0.60 to 0.95; p = 0.006). Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (aOR 0.98, 95% CI 0.80 to 1.20; p = 0.83). The body of evidence contributing to these analyses was assessed as being of high quality.RESULTSWe identified 25 eligible RCTs (a total of 11,321 participants, aged from 0 to 95 years). IPD were obtained for 10,933 out of 11,321 (96.6%) participants. Vitamin D supplementation reduced the risk of ARI among all participants [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.81 to 0.96; heterogeneity p < 0.001]. Subgroup analysis revealed that protective effects were seen in individuals receiving daily or weekly vitamin D without additional bolus doses (aOR 0.81, 95% CI 0.72 to 0.91), but not in those receiving one or more bolus doses (aOR 0.97, 95% CI 0.86 to 1.10; p = 0.05). Among those receiving daily or weekly vitamin D, protective effects of vitamin D were stronger in individuals with a baseline 25-hydroxyvitamin D [25(OH)D] concentration of < 25 nmol/l (aOR 0.30, 95% CI 0.17 to 0.53) than in those with a baseline 25(OH)D concentration of ≥ 25 nmol/l (aOR 0.75, 95% CI 0.60 to 0.95; p = 0.006). Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (aOR 0.98, 95% CI 0.80 to 1.20; p = 0.83). The body of evidence contributing to these analyses was assessed as being of high quality.Our study had limited power to detect the effects of vitamin D supplementation on the risk of upper versus lower respiratory infection, analysed separately.LIMITATIONSOur study had limited power to detect the effects of vitamin D supplementation on the risk of upper versus lower respiratory infection, analysed separately.Vitamin D supplementation was safe, and it protected against ARIs overall. Very deficient individuals and those not receiving bolus doses experienced the benefit. Incorporation of additional IPD from ongoing trials in the field has the potential to increase statistical power for analyses of secondary outcomes.CONCLUSIONSVitamin D supplementation was safe, and it protected against ARIs overall. Very deficient individuals and those not receiving bolus doses experienced the benefit. Incorporation of additional IPD from ongoing trials in the field has the potential to increase statistical power for analyses of secondary outcomes.This study is registered as PROSPERO CRD42014013953.STUDY REGISTRATIONThis study is registered as PROSPERO CRD42014013953.The National Institute for Health Research Health Technology Assessment programme.FUNDINGThe National Institute for Health Research Health Technology Assessment programme. Background: Randomised controlled trials (RCTs) exploring the potential of vitamin D to prevent acute respiratory infections have yielded mixed results. Individual participant data (IPD) meta-analysis has the potential to identify factors that may explain this heterogeneity. Objectives: To assess the overall effect of vitamin D supplementation on the risk of acute respiratory infections (ARIs) and to identify factors modifying this effect. Data sources: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, ClinicalTrials.gov and the International Standard Randomised Controlled Trials Number (ISRCTN) registry. Study selection: Randomised, double-blind, placebo-controlled trials of supplementation with vitamin D3 or vitamin D2 of any duration having incidence of acute respiratory infection as a prespecified efficacy outcome were selected. Study appraisal: Study quality was assessed using the Cochrane Collaboration Risk of Bias tool to assess sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, completeness of outcome data, evidence of selective outcome reporting and other potential threats to validity. Results: We identified 25 eligible RCTs (a total of 11,321 participants, aged from 0 to 95 years). IPD were obtained for 10,933 out of 11,321 (96.6%) participants. Vitamin D supplementation reduced the risk of ARI among all participants [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.81 to 0.96; heterogeneity p < 0.001]. Subgroup analysis revealed that protective effects were seen in individuals receiving daily or weekly vitamin D without additional bolus doses (aOR 0.81, 95% CI 0.72 to 0.91), but not in those receiving one or more bolus doses (aOR 0.97, 95% CI 0.86 to 1.10; p = 0.05). Among those receiving daily or weekly vitamin D, protective effects of vitamin D were stronger in individuals with a baseline 25-hydroxyvitamin D [25(OH)D] concentration of < 25 nmol/l (aOR 0.30, 95% CI 0.17 to 0.53) than in those with a baseline 25(OH)D concentration of ≥ 25 nmol/l (aOR 0.75, 95% CI 0.60 to 0.95; p = 0.006). Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (aOR 0.98, 95% CI 0.80 to 1.20; p = 0.83). The body of evidence contributing to these analyses was assessed as being of high quality. Limitations: Our study had limited power to detect the effects of vitamin D supplementation on the risk of upper versus lower respiratory infection, analysed separately. Conclusions: Vitamin D supplementation was safe, and it protected against ARIs overall. Very deficient individuals and those not receiving bolus doses experienced the benefit. Incorporation of additional IPD from ongoing trials in the field has the potential to increase statistical power for analyses of secondary outcomes. Study registration: This study is registered as PROSPERO CRD42014013953. Funding: The National Institute for Health Research Health Technology Assessment programme. |
| Author | Jolliffe, David A Bergman, Peter Kerley, Conor P Manaseki-Holland, Semira Stelmach, Iwona Greenberg, Lauren Camargo, Carlos A Jensen, Megan E Ganmaa, Davaasambuu Murdoch, David R Griffiths, Christopher J Janssens, Wim Aloia, John F Rees, Judy R Esposito, Susanna Neale, Rachel Mauger, David Dubnov-Raz, Gal Ginde, Adit A Trilok Kumar, Geeta Hooper, Richard L Martineau, Adrian R Laaksi, Ilkka Urashima, Mitsuyoshi Grant, Cameron C Simpson, Steve Goodall, Emma C |
| Author_xml | – sequence: 1 givenname: Adrian R orcidid: 0000-0001-5387-1721 surname: Martineau fullname: Martineau, Adrian R organization: Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK, Asthma UK Centre for Applied Research, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK – sequence: 2 givenname: David A orcidid: 0000-0003-3592-1945 surname: Jolliffe fullname: Jolliffe, David A organization: Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK – sequence: 3 givenname: Lauren orcidid: 0000-0003-0581-3636 surname: Greenberg fullname: Greenberg, Lauren organization: Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK – sequence: 4 givenname: John F orcidid: 0000-0002-4130-7717 surname: Aloia fullname: Aloia, John F organization: Bone Mineral Research Center, Winthrop University Hospital, Mineola, NY, USA – sequence: 5 givenname: Peter orcidid: 0000-0003-3306-3713 surname: Bergman fullname: Bergman, Peter organization: Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden – sequence: 6 givenname: Gal orcidid: 0000-0003-1469-8043 surname: Dubnov-Raz fullname: Dubnov-Raz, Gal organization: Deptartment of Exercise, Lifestyle and Nutrition Clinic, Edmond and Lily Safra Children’s Hospital, Tel Hashomer, Israel – sequence: 7 givenname: Susanna orcidid: 0000-0003-4103-2837 surname: Esposito fullname: Esposito, Susanna organization: Pediatric Highly Intensive Care Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy – sequence: 8 givenname: Davaasambuu orcidid: 0000-0003-3388-8475 surname: Ganmaa fullname: Ganmaa, Davaasambuu organization: Department of Nutrition, Harvard School of Public Health, Boston, MA, USA – sequence: 9 givenname: Adit A surname: Ginde fullname: Ginde, Adit A organization: Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA – sequence: 10 givenname: Emma C orcidid: 0000-0001-5647-4123 surname: Goodall fullname: Goodall, Emma C organization: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada – sequence: 11 givenname: Cameron C orcidid: 0000-0002-4032-7230 surname: Grant fullname: Grant, Cameron C organization: Department of Paediatrics: Child and Youth Health, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand – sequence: 12 givenname: Wim orcidid: 0000-0003-1830-2982 surname: Janssens fullname: Janssens, Wim organization: Universitaire ziekenhuizen Leuven, Leuven, Belgium – sequence: 13 givenname: Megan E orcidid: 0000-0001-8653-4801 surname: Jensen fullname: Jensen, Megan E organization: Centre for Asthma and Respiratory Diseases, University of Newcastle, Newcastle, NSW, Australia – sequence: 14 givenname: Conor P orcidid: 0000-0002-1529-8052 surname: Kerley fullname: Kerley, Conor P organization: Dublin City University, Dublin, Ireland – sequence: 15 givenname: Ilkka orcidid: 0000-0002-4565-0483 surname: Laaksi fullname: Laaksi, Ilkka organization: Centre for Military Medicine, Finnish Defense Forces, University of Tampere, Tampere, Finland – sequence: 16 givenname: Semira orcidid: 0000-0001-5827-8855 surname: Manaseki-Holland fullname: Manaseki-Holland, Semira organization: Department of Public Health, Epidemiology and Biostatistics, Institute of Applied Health Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK – sequence: 17 givenname: David orcidid: 0000-0002-4663-5285 surname: Mauger fullname: Mauger, David organization: Department of Statistics, The Pennsylvania State University, Hershey, PA, USA – sequence: 18 givenname: David R orcidid: 0000-0003-0070-8001 surname: Murdoch fullname: Murdoch, David R organization: Department of Pathology, University of Otago, Christchurch, New Zealand – sequence: 19 givenname: Rachel orcidid: 0000-0001-7162-0854 surname: Neale fullname: Neale, Rachel organization: Queensland Institute of Medical Research Berghofer Medical Research Institute, Brisbane, QLD, Australia – sequence: 20 givenname: Judy R surname: Rees fullname: Rees, Judy R organization: Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA – sequence: 21 givenname: Steve orcidid: 0000-0001-6521-3056 surname: Simpson fullname: Simpson, Steve organization: Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia – sequence: 22 givenname: Iwona orcidid: 0000-0002-7208-8326 surname: Stelmach fullname: Stelmach, Iwona organization: Department of Pediatrics and Allergy, Medical University of Łódź, Łódź, Poland – sequence: 23 givenname: Geeta surname: Trilok Kumar fullname: Trilok Kumar, Geeta organization: Institute of Home Economics, University of Delhi, New Delhi, India – sequence: 24 givenname: Mitsuyoshi orcidid: 0000-0002-7395-5831 surname: Urashima fullname: Urashima, Mitsuyoshi organization: Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan – sequence: 25 givenname: Carlos A orcidid: 0000-0002-5071-7654 surname: Camargo fullname: Camargo, Carlos A organization: Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA – sequence: 26 givenname: Christopher J orcidid: 0000-0001-7935-8694 surname: Griffiths fullname: Griffiths, Christopher J organization: Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK, Asthma UK Centre for Applied Research, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK, Medical Research Council and Asthma UK Centre in Allergic Mechanisms of Asthma, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK – sequence: 27 givenname: Richard L orcidid: 0000-0002-1063-0917 surname: Hooper fullname: Hooper, Richard L organization: Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30675873$$D View this record in MEDLINE/PubMed http://kipublications.ki.se/Default.aspx?queryparsed=id:140130309$$DView record from Swedish Publication Index |
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| SubjectTerms | Adolescent Adult Age Factors Aged Aged, 80 and over Body Mass Index Child Child, Preschool Cholecalciferol - administration & dosage Comorbidity Dietary Supplements Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Ergocalciferols - administration & dosage Female Humans Infant Influenza Vaccines - administration & dosage Male Middle Aged Randomized Controlled Trials as Topic Respiratory Tract Infections - prevention & control Vitamin D - administration & dosage Vitamin D - therapeutic use Vitamin D Deficiency - drug therapy Young Adult |
| Title | Vitamin D supplementation to prevent acute respiratory infections: individual participant data meta-analysis |
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