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| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
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Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.
The study population will comprise sheltered accommodation residents and staff fulfilling eligibility criteria. Half of the sheltered accommodation schemes will be randomly allocated to 2-monthly oral bolus vitamin D supplementation (Vigantol oil) over a period of one year, and half to placebo.
Participants will be followed for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miglyol oil | Placebo Comparator | Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year |
|
| Vigantol oil | Active Comparator | Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol (Vitamin D/Vigantol oil) | Dietary Supplement | Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff | One year | |
| Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian R Martineau, MRCP | Queen Mary University of London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanover in Hackney Housing Association | London | United Kingdom | ||||
| Sanctuary Group Housing Association |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26063508 | Derived | Martineau AR, Hanifa Y, Witt KD, Barnes NC, Hooper RL, Patel M, Stevens N, Enayat Z, Balayah Z, Syed A, Knight A, Jolliffe DA, Greiller CL, McLaughlin D, Venton TR, Rowe M, Timms PM, Clark D, Sadique Z, Eldridge SM, Griffiths CJ. 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 Oct;70(10):953-60. doi: 10.1136/thoraxjnl-2015-206996. Epub 2015 Jun 10. |
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|
| Miglyol oil | Dietary Supplement | Miglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year |
|
| Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff | One year |
| Proportion of participants experiencing hypercalcaemia | One year |
| London |
| United Kingdom |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007251 | Influenza, Human |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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