Created at Source Raw Value Validated value
Jan. 21, 2021, 3:02 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Homes; and not participants; will be randomised. Randomisation will be stratified by care home type (residential vs nursing/mixed); prior COVID-19 in phase 1 of pandemic (yes vs no); and size of care home (number of residents <32 vs >32). Residents and care home staff are blinded; with a double-blind design. Participants will be randomly allocated to receive either: 1. Nitric Oxide in the form of 70 ml of beetroot juice containing 400 mg nitrate given once daily for 60 days 2. Placebo in the form of 70 ml of beetroot juice containing 0 mg nitrate given once daily for 60 days The intervention and placebo are foods and not investigational products. Active beetroot juice is available from supermarkets and on-line. Participants will be invited for three follow-up visits. The first follow up visit will occur on day 14; where saliva/urine nitrate/nitrite test; dietary nitrate intake from menu; and beetroot juice adherence will be assessed. The second follow up visit will be on day 60; where the clinical tests Clinical Frailty Index (CFI); Barthel index (BI); 6 item cognitive impairment test (6CIT); quality of life visual analogue scale (EQ-VAS); and EuroQol 5-dimension 5-level (EQ-5D-5L) quality of life questionnaire; as well as dietary nitrate intake from menu and saliva/urine nitrate/nitrite test will be assessed. The final follow up visit will be on day 90 where saliva/urine nitrate/nitrite test and dietary nitrate intake from menu will be assessed.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "1. Nitric Oxide in the form of 70 ml of beetroot juice containing 400 mg nitrate given once daily for 60 days", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "2. Placebo in the form of 70 ml of beetroot juice containing 0 mg nitrate given once daily for 60 days", "treatment_type": "Placebo", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]