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Vitamin D3 and gargling for the prevention of upper respiratory tract infections: a randomized controlled trial.

Abstract

BACKGROUND

We undertook a 2X2 factorial, randomized controlled trial (RCT) to assess whether vitamin D3 supplementation (10,000 international units per week) versus placebo and gargling versus no gargling could prevent viral, clinical upper respiratory tract infection (URTI) in university students.

METHODS

We randomized 600 students into 4 treatment arms: 1) vitamin D3 and gargling, 2) placebo and gargling, 3) vitamin D3 and no gargling, and 4) placebo and no gargling. Students completed weekly electronic surveys and submitted self-collected mid-turbinate nasal flocked swabs during September and October in 2010 or 2011. Symptomatic students also completed an electronic symptom diary. The primary and secondary outcomes were the occurrence of symptomatic clinical URTI and laboratory confirmed URTI respectively.

RESULTS

Of 600 participants, 471 (78.5%) completed all surveys while 43 (7.2%) completed none; 150 (25.0%) reported clinical URTI. Seventy participants (23.3%) randomized to vitamin D3 reported clinical URTI compared to 80 (26.7%) randomized to placebo (RR:0.79, CI95:0.61-1.03, p = 0.09). Eighty-five participants (28.3%) randomized to gargling reported clinical URTI compared to 65 participants (21.7%) randomized to the no gargling arm (RR:1.3, CI95:0.92-1.57, p = 0.19). Laboratory testing identified 70 infections (46.7 per 100 URTIs). Vitamin D3 treatment was associated with a significantly lower risk for laboratory confirmed URTI (RR: 0.54, CI95:0.34-0.84, p = 0.007) and with a significantly lower mean viral load measured as log10 viral copies/mL (mean difference: -0.89, CI95: -1.7, -0.06, p = 0.04). Fewer students assigned to gargling experienced laboratory confirmed URTI, however this was not statistically significant (RR:0.82, CI95:0.53-1.26, p = 0.36).

CONCLUSIONS

These results suggest that vitamin D3 is a promising intervention for the prevention of URTI. Vitamin D3 significantly reduced the risk of laboratory confirmed URTI and may reduce the risk of clinical infections.

TRIAL REGISTRATION

CLINICAL TRIALS REGISTRATION

NCT01158560.

Links

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  • Authors+Show Affiliations

    , , , , , ,

    Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. smiejam@mcmaster.ca.

    Source

    BMC infectious diseases 14: 2014 May 19 pg 273

    MeSH

    Adolescent
    Biomedical Research
    Cholecalciferol
    Dietary Supplements
    Female
    Health Behavior
    Healthy Volunteers
    Humans
    Male
    Respiratory Tract Infections
    Risk
    Students
    Vitamins
    Young Adult

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    24885201

    Citation

    Goodall, Emma C., et al. "Vitamin D3 and Gargling for the Prevention of Upper Respiratory Tract Infections: a Randomized Controlled Trial." BMC Infectious Diseases, vol. 14, 2014, p. 273.
    Goodall EC, Granados AC, Luinstra K, et al. Vitamin D3 and gargling for the prevention of upper respiratory tract infections: a randomized controlled trial. BMC Infect Dis. 2014;14:273.
    Goodall, E. C., Granados, A. C., Luinstra, K., Pullenayegum, E., Coleman, B. L., Loeb, M., & Smieja, M. (2014). Vitamin D3 and gargling for the prevention of upper respiratory tract infections: a randomized controlled trial. BMC Infectious Diseases, 14, p. 273. doi:10.1186/1471-2334-14-273.
    Goodall EC, et al. Vitamin D3 and Gargling for the Prevention of Upper Respiratory Tract Infections: a Randomized Controlled Trial. BMC Infect Dis. 2014 May 19;14:273. PubMed PMID: 24885201.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Vitamin D3 and gargling for the prevention of upper respiratory tract infections: a randomized controlled trial. AU - Goodall,Emma C, AU - Granados,Andrea C, AU - Luinstra,Kathy, AU - Pullenayegum,Eleanor, AU - Coleman,Brenda L, AU - Loeb,Mark, AU - Smieja,Marek, Y1 - 2014/05/19/ PY - 2013/09/15/received PY - 2014/05/02/accepted PY - 2014/6/3/entrez PY - 2014/6/3/pubmed PY - 2014/12/31/medline SP - 273 EP - 273 JF - BMC infectious diseases JO - BMC Infect. Dis. VL - 14 N2 - BACKGROUND: We undertook a 2X2 factorial, randomized controlled trial (RCT) to assess whether vitamin D3 supplementation (10,000 international units per week) versus placebo and gargling versus no gargling could prevent viral, clinical upper respiratory tract infection (URTI) in university students. METHODS: We randomized 600 students into 4 treatment arms: 1) vitamin D3 and gargling, 2) placebo and gargling, 3) vitamin D3 and no gargling, and 4) placebo and no gargling. Students completed weekly electronic surveys and submitted self-collected mid-turbinate nasal flocked swabs during September and October in 2010 or 2011. Symptomatic students also completed an electronic symptom diary. The primary and secondary outcomes were the occurrence of symptomatic clinical URTI and laboratory confirmed URTI respectively. RESULTS: Of 600 participants, 471 (78.5%) completed all surveys while 43 (7.2%) completed none; 150 (25.0%) reported clinical URTI. Seventy participants (23.3%) randomized to vitamin D3 reported clinical URTI compared to 80 (26.7%) randomized to placebo (RR:0.79, CI95:0.61-1.03, p = 0.09). Eighty-five participants (28.3%) randomized to gargling reported clinical URTI compared to 65 participants (21.7%) randomized to the no gargling arm (RR:1.3, CI95:0.92-1.57, p = 0.19). Laboratory testing identified 70 infections (46.7 per 100 URTIs). Vitamin D3 treatment was associated with a significantly lower risk for laboratory confirmed URTI (RR: 0.54, CI95:0.34-0.84, p = 0.007) and with a significantly lower mean viral load measured as log10 viral copies/mL (mean difference: -0.89, CI95: -1.7, -0.06, p = 0.04). Fewer students assigned to gargling experienced laboratory confirmed URTI, however this was not statistically significant (RR:0.82, CI95:0.53-1.26, p = 0.36). CONCLUSIONS: These results suggest that vitamin D3 is a promising intervention for the prevention of URTI. Vitamin D3 significantly reduced the risk of laboratory confirmed URTI and may reduce the risk of clinical infections. TRIAL REGISTRATION: CLINICAL TRIALS REGISTRATION: NCT01158560. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/24885201/full_citation L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/1471-2334-14-273 DB - PRIME DP - Unbound Medicine ER -