Upper Respiratory Infections Clinical Trial
Official title:
Effect of Supplementation With Multivitamins and Minerals on the Incidence of Respiratory Infections in Older People in Ecuador: a Randomised Controlled Trial.
Poor Ecuadorian older people suffer from chronic dietary deficiencies of zinc, iron, copper, vitamins C, B6, B12, D, and folic acid. The investigators have previously shown that these deficiencies are associated with impaired immune function and increased incidence of respiratory infections (RI). The hypothesis is that correction of these specific nutrient deficiencies will improve immune response and thereby enhance resistance to respiratory infections. To test this hypothesis this study will evaluate the effect of supplementation with specific vitamins and minerals found to be deficient in poor elderly Ecuadorians on markers of immune function and the incidence of RI. A randomized, double-blind, placebo-controlled trial in 320 older people (≥65 y)will be carried out in Quito, Ecuador. Participants will receive multivitamin and mineral supplements or placebo tablets daily for 12 months. Nutrients will be provided at US Recommended Daily Allowance (RDA) levels, except for vitamin C and zinc doses, which will be 5 times and 1.25 times higher than the RDA, respectively. Incidence of respiratory infections (the primary outcome) will be assessed weekly by field nurses and physicians from the study team. Secondary outcomes include delayed-type hypersensitivity (DTH) skin test, cathelicidin production by mucosa respiratory cells, and serum C-reactive protein (CRP) as measures of immune function. Blood micronutrient levels and haemoglobin status will be collected as measures of adherence to the trial regimen. Incidence rate of RI and rate ratio (RR) will be calculated to quantify the effect of the intervention on the incidence of respiratory infection. This will be the first trial of its kind conducted specifically in a population of older people known to have poor micronutrient status. The findings of the study may be important for similar populations in other low- and middle-income countries.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | December 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Age =65 years - Mental competence - Written informed consent Exclusion Criteria: - Cancer - Tuberculosis - Immunosuppressive therapeutics. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Ecuador | Atucucho neighborhood | Quito | Pichincha |
Lead Sponsor | Collaborator |
---|---|
Corporacion Ecuatoriana de Biotecnologia | Central University, Ecuador |
Ecuador,
Hamer DH, Sempértegui F, Estrella B, Tucker KL, Rodríguez A, Egas J, Dallal GE, Selhub J, Griffiths JK, Meydani SN. Micronutrient deficiencies are associated with impaired immune response and higher burden of respiratory infections in elderly Ecuadorians. J Nutr. 2009 Jan;139(1):113-9. doi: 10.3945/jn.108.095091. Epub 2008 Dec 3. — View Citation
Sempértegui F, Estrella B, Elmieh N, Jordan M, Ahmed T, Rodríguez A, Tucker KL, Hamer DH, Reeves PG, Meydani SN. Nutritional, immunological and health status of the elderly population living in poor neighbourhoods of Quito, Ecuador. Br J Nutr. 2006 Nov;96(5):845-53. — View Citation
Sempértegui F, Estrella B, Tucker KL, Hamer DH, Narvaez X, Sempértegui M, Griffiths JK, Noel SE, Dallal GE, Selhub J, Meydani SN. Metabolic syndrome in the elderly living in marginal peri-urban communities in Quito, Ecuador. Public Health Nutr. 2011 May;14(5):758-67. doi: 10.1017/S1368980010002636. Epub 2010 Oct 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of respiratory infections (upper plus lower) | 52 weeks | Yes | |
Secondary | Mean score of DTH response to Trichophyton and tetanus toxoid | 52 weeks | No | |
Secondary | CRP blood concentration | 52 weeks | No | |
Secondary | Cathelicidin concentration in supernatants of cultured respiratory mucosa cells | 52 weeks | No |
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