Nutritional Intervention and Respiratory Infections in Older Subjects

NCT01971112 | Unknown DMC

• 1 other identifier: 378 DGIP-I
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Respiratory Infections; Lower Respiratory Tract Infections

Keywords

Multi-vitamins; Minerals; Respiratory infections; DTH; CRP; Cathelicidin

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory infections (upper plus lower)

  52 weeks

Secondary Outcomes (3)

• Mean score of DTH response to Trichophyton and tetanus toxoid

  52 weeks

• CRP blood concentration

  52 weeks

• Cathelicidin concentration in supernatants of cultured respiratory mucosa cells

  52 weeks

Study Arms (2)

Multivitamins and minerals

EXPERIMENTAL

Experimental: X: Multivitamins and minerals (MVM) Arm X: 1X US-RDA of vitamins A, D,E,B6,B12, folate, copper and iron plus 500 mg vitamin C, and 14 mg of Zinc

Dietary Supplement: Multivitamins and minerals

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Multivitamins and minerals

Interventions

Multivitamins and minerals DIETARY_SUPPLEMENT

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.

Multivitamins and minerals; Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years
• Mental competence
• Written informed consent

You may not qualify if:

• Cancer
• Tuberculosis
• Immunosuppressive therapeutics.

Sponsors & Collaborators

• Corporacion Ecuatoriana de Biotecnologia: lead
• Universidad Central del Ecuador: collaborator

Study Sites (1)

Atucucho neighborhood

Quito, Pichincha, Ecuador

RECRUITING

Related Publications (3)

• Sempertegui F, Estrella B, Tucker KL, Hamer DH, Narvaez X, Sempertegui 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.

  PMID: 20955641 BACKGROUND

• Hamer DH, Sempertegui F, Estrella B, Tucker KL, Rodriguez 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.

  PMID: 19056665 BACKGROUND

• Sempertegui F, Estrella B, Elmieh N, Jordan M, Ahmed T, Rodriguez 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. doi: 10.1017/bjn20061802.

  PMID: 17092372 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Geritol; Minerals

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Central Study Contacts

Fernando E Sempertegui, MD

CONTACT

593 2 2557673; fersempert@biociencias-ceb.org

Bertha Estrella, MD

CONTACT

593 2 2520638; bestrel@biociencias-ceb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

EC (1)