Nutritional Intervention and Respiratory Infections in Older Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Corporacion Ecuatoriana de Biotecnologia
Sponsor:
Collaborator:
Central University, Ecuador
Information provided by (Responsible Party):
Fernando Sempertegui MD, Corporacion Ecuatoriana de Biotecnologia
ClinicalTrials.gov Identifier:
NCT01971112
First received: October 10, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Upper Respiratory Infections
Lower Respiratory Tract Infections
Dietary Supplement: Multivitamins and minerals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Supplementation With Multivitamins and Minerals on the Incidence of Respiratory Infections in Older People in Ecuador: a Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Corporacion Ecuatoriana de Biotecnologia:

Primary Outcome Measures:
  • Incidence of respiratory infections (upper plus lower) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean score of DTH response to Trichophyton and tetanus toxoid [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • CRP blood concentration [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Cathelicidin concentration in supernatants of cultured respiratory mucosa cells [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multivitamins and minerals
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
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.
Placebo Comparator: Placebo 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cancer
  • Tuberculosis
  • Immunosuppressive therapeutics.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971112

Contacts
Contact: Fernando E Sempertegui, MD 593 2 2557673 fersempert@biociencias-ceb.org
Contact: Bertha Estrella, MD 593 2 2520638 bestrel@biociencias-ceb.org

Locations
Ecuador
Atucucho neighborhood Recruiting
Quito, Pichincha, Ecuador
Contact: Fernando E Sempertegui, MD    593 2 2557673    fersempert@biociencias-ceb.org   
Principal Investigator: Fernando E Sempertegui, MD         
Sponsors and Collaborators
Corporacion Ecuatoriana de Biotecnologia
Central University, Ecuador
  More Information

Publications:
Responsible Party: Fernando Sempertegui MD, Principal Investigator, Corporacion Ecuatoriana de Biotecnologia
ClinicalTrials.gov Identifier: NCT01971112     History of Changes
Other Study ID Numbers: 378 DGIP-I
Study First Received: October 10, 2013
Last Updated: October 23, 2013
Health Authority: Ecuador: Public Health Ministry

Keywords provided by Corporacion Ecuatoriana de Biotecnologia:
Multi-vitamins
Minerals
Respiratory infections
DTH
CRP
Cathelicidin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014