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Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu).

Abstract

RATIONALE

Low-dose vitamin D supplementation is already recommended in older adults for prevention of fractures and falls, but clinical trials investigating whether higher doses could provide additional protection against acute respiratory infection (ARI) are lacking.

OBJECTIVE

To conduct a clinical trial of high-dose versus low-dose vitamin D3 supplementation for ARI prevention in residents of sheltered-accommodation housing blocks ('schemes') and their carers in London, UK.

MEASUREMENTS AND METHODS

Fifty-four schemes (137 individual participants) were allocated to the active intervention (vitamin D3 2.4 mg once every 2 months +10 μg daily for residents, 3 mg once every 2 months for carers), and 54 schemes with 103 participants were allocated to control (placebo once every 2 months +vitamin D3 10 μg daily for residents, placebo once every 2 months for carers) for 1 year. Primary outcome was time to first ARI; secondary outcomes included time to first upper/lower respiratory infection (URI/LRI, analysed separately), and symptom duration.

MAIN RESULTS

Inadequate vitamin D status was common at baseline: 220/240 (92%) participants had serum 25(OH)D concentration <75 nmol/L. The active intervention did not influence time to first ARI (adjusted HR (aHR) 1.18, 95% CI 0.80 to 1.74, p=0.42). When URI and LRI were analysed separately, allocation to the active intervention was associated with increased risk of URI (aHR 1.48, 95% CI 1.02 to 2.16, p=0.039) and increased duration of URI symptoms (median 7.0 vs 5.0 days for active vs control, adjusted ratio of geometric means 1.34, 95% CI 1.09 to 1.65, p=0.005), but not with altered risk or duration of LRI.

CONCLUSIONS

Addition of intermittent bolus-dose vitamin D3 supplementation to a daily low-dose regimen did not influence risk of ARI in older adults and their carers, but was associated with increased risk and duration of URI.

TRIAL REGISTRATION NUMBER

clinicaltrials.gov NCT01069874.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

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    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK Asthma UK Centre for Applied Research, Blizard Institute, Queen Mary University of London, London, UK.

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    London School of Hygiene and Tropical Medicine, London, UK.

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    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

    ,

    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

    ,

    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

    ,

    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

    ,

    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK Advanced Medical and Dental Institute, Universiti Sains Malaysia, Penang, Malaysia.

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    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

    ,

    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Homerton University Hospital, London, UK.

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    Homerton University Hospital, London, UK.

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    Homerton University Hospital, London, UK.

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    Royal London Hospital, London, UK.

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    London School of Hygiene and Tropical Medicine, London, UK.

    ,

    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

    Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

    Source

    Thorax 70:10 2015 Oct pg 953-60

    MeSH

    Acute Disease
    Aged
    Caregivers
    Cholecalciferol
    Dietary Supplements
    Dose-Response Relationship, Drug
    Double-Blind Method
    Drug Administration Schedule
    Female
    Humans
    Male
    Middle Aged
    Nursing Homes
    Respiratory Tract Infections
    Vitamins

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    26063508

    Citation

    Martineau, Adrian R., et al. "Double-blind Randomised Controlled Trial of Vitamin D3 Supplementation for the Prevention of Acute Respiratory Infection in Older Adults and Their Carers (ViDiFlu)." Thorax, vol. 70, no. 10, 2015, pp. 953-60.
    Martineau AR, Hanifa Y, Witt KD, et al. Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu). Thorax. 2015;70(10):953-60.
    Martineau, A. R., Hanifa, Y., Witt, K. D., Barnes, N. C., Hooper, R. L., Patel, M., ... Griffiths, C. J. (2015). Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu). Thorax, 70(10), pp. 953-60. doi:10.1136/thoraxjnl-2015-206996.
    Martineau AR, et al. Double-blind Randomised Controlled Trial of Vitamin D3 Supplementation for the Prevention of Acute Respiratory Infection in Older Adults and Their Carers (ViDiFlu). Thorax. 2015;70(10):953-60. PubMed PMID: 26063508.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu). AU - Martineau,Adrian R, AU - Hanifa,Yasmeen, AU - Witt,Karolina D, AU - Barnes,Neil C, AU - Hooper,Richard L, AU - Patel,Mital, AU - Stevens,Natasha, AU - Enayat,Zinat, AU - Balayah,Zuhur, AU - Syed,Asmat, AU - Knight,Aishah, AU - Jolliffe,David A, AU - Greiller,Claire L, AU - McLaughlin,David, AU - Venton,Timothy R, AU - Rowe,Marion, AU - Timms,Peter M, AU - Clark,Duncan, AU - Sadique,Zia, AU - Eldridge,Sandra M, AU - Griffiths,Christopher J, Y1 - 2015/06/10/ PY - 2015/03/03/received PY - 2015/05/26/accepted PY - 2015/6/12/entrez PY - 2015/6/13/pubmed PY - 2015/12/17/medline KW - Respiratory Infection SP - 953 EP - 60 JF - Thorax JO - Thorax VL - 70 IS - 10 N2 - RATIONALE: Low-dose vitamin D supplementation is already recommended in older adults for prevention of fractures and falls, but clinical trials investigating whether higher doses could provide additional protection against acute respiratory infection (ARI) are lacking. OBJECTIVE: To conduct a clinical trial of high-dose versus low-dose vitamin D3 supplementation for ARI prevention in residents of sheltered-accommodation housing blocks ('schemes') and their carers in London, UK. MEASUREMENTS AND METHODS: Fifty-four schemes (137 individual participants) were allocated to the active intervention (vitamin D3 2.4 mg once every 2 months +10 μg daily for residents, 3 mg once every 2 months for carers), and 54 schemes with 103 participants were allocated to control (placebo once every 2 months +vitamin D3 10 μg daily for residents, placebo once every 2 months for carers) for 1 year. Primary outcome was time to first ARI; secondary outcomes included time to first upper/lower respiratory infection (URI/LRI, analysed separately), and symptom duration. MAIN RESULTS: Inadequate vitamin D status was common at baseline: 220/240 (92%) participants had serum 25(OH)D concentration <75 nmol/L. The active intervention did not influence time to first ARI (adjusted HR (aHR) 1.18, 95% CI 0.80 to 1.74, p=0.42). When URI and LRI were analysed separately, allocation to the active intervention was associated with increased risk of URI (aHR 1.48, 95% CI 1.02 to 2.16, p=0.039) and increased duration of URI symptoms (median 7.0 vs 5.0 days for active vs control, adjusted ratio of geometric means 1.34, 95% CI 1.09 to 1.65, p=0.005), but not with altered risk or duration of LRI. CONCLUSIONS: Addition of intermittent bolus-dose vitamin D3 supplementation to a daily low-dose regimen did not influence risk of ARI in older adults and their carers, but was associated with increased risk and duration of URI. TRIAL REGISTRATION NUMBER: clinicaltrials.gov NCT01069874. SN - 1468-3296 UR - https://www.unboundmedicine.com/medline/citation/26063508/Double_blind_randomised_controlled_trial_of_vitamin_D3_supplementation_for_the_prevention_of_acute_respiratory_infection_in_older_adults_and_their_carers__ViDiFlu__ L2 - http://thorax.bmj.com/cgi/pmidlookup?view=long&amp;pmid=26063508 DB - PRIME DP - Unbound Medicine ER -