Goodall 2014.
Study characteristics | ||
Methods | A 2X2 factorial RCT with 4 treatment arms
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Participants | 600 students from McMaster University, Hamilton, Ontario, Canada, randomised to the following.
Inclusion criteria: aged ≥ 17 years and lived with at least 1 student house mate. Exclusion criteria: students with contraindicated medical conditions (hypercalcaemia, parathyroid disorder, chronic kidney disease, use of anticonvulsants, malabsorption syndromes, sarcoidosis), who were currently or planning to become pregnant, who were taking ≥ 1000 international units (IU)/day vitamin D, or who were unable to swallow capsules |
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Interventions | See Table 4 for details. | |
Outcomes | Laboratory (influenza assessed via weekly self‐collected nasal swabs; only swabs for symptomatic participants were assessed). Lab‐confirmed influenza was determined by testing the Day 1 nasal swabs using an in‐house enterovirus/rhinovirus PCR and, if negative, a commercial multiplex PCR able to detect 16 respiratory viruses and viral subtypes (xTAG RVP FAST, Luminex, Austin TX). Clinical URTI assessed via weekly online surveys. Clinical URTI is defined as the participant’s perception of cold in conjunction with 1 or more symptoms (runny/stuffy nose, congestion, cough, sneezing, sore throat, muscle aches, or fever). When participants reported symptoms but were uncertain if they were ill, adjudication was applied by 2 clinicians. Safety: None assessed/reported by the investigators. |
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Notes | Study was conducted during 2 periods: September to October in 2010 and 2011. Partial governmental funding. Competing interests: the authors declare that they have no competing interests. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description on how the randomisation sequence was generated |
Allocation concealment (selection bias) | Low risk | Study used opaque, sealed, serially numbered envelopes. Envelopes were only accessed when both personnel were present. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Due to the nature of gargling with tap water, this intervention was not blinded. However, all other aspects of the study were blinded. Self‐reported symptoms were adjudicated by 2 clinicians. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Except for gargling, all other participants and study personnel were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study flow chart and reasons for lost to follow‐up are provided, imputation used for missing outcomes. |
Selective reporting (reporting bias) | Low risk | All planned study outcomes were reported and match the published study protocol. |