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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01971112
Other study ID # 378 DGIP-I
Secondary ID
Status Recruiting
Phase N/A
First received October 10, 2013
Last updated October 23, 2013
Start date October 2013
Est. completion date December 2014

Study information

Verified date October 2013
Source Corporacion Ecuatoriana de Biotecnologia
Contact Fernando E Sempertegui, MD
Phone 593 2 2557673
Email fersempert@biociencias-ceb.org
Is FDA regulated No
Health authority Ecuador: Public Health Ministry
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Multivitamins and minerals
Dietary supplement Arm X: Vitamins B6, B12,folic acid, A, D, E, and Iron, and copper at one US-RDA. Plus vitamin C 500 mg, and zinc 14 mg will be given orally daily during 52 weeks.

Locations

Country Name City State
Ecuador Atucucho neighborhood Quito Pichincha

Sponsors (2)

Lead Sponsor Collaborator
Corporacion Ecuatoriana de Biotecnologia Central University, Ecuador

Country where clinical trial is conducted

Ecuador, 

References & Publications (3)

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

Outcome

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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