ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Intervention and Respiratory Infections in Older Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01971112
Recruitment Status : Unknown
Verified October 2013 by Fernando Sempertegui MD, Corporacion Ecuatoriana de Biotecnologia.
Recruitment status was:  Recruiting
First Posted : October 29, 2013
Last Update Posted : October 29, 2013
Sponsor:
Collaborator:
Central University, Ecuador
Information provided by (Responsible Party):
Fernando Sempertegui MD, Corporacion Ecuatoriana de Biotecnologia

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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Infections Lower Respiratory Tract Infections Dietary Supplement: Multivitamins and minerals Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : October 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Incidence of respiratory infections (upper plus lower) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Mean score of DTH response to Trichophyton and tetanus toxoid [ Time Frame: 52 weeks ]
  2. CRP blood concentration [ Time Frame: 52 weeks ]
  3. Cathelicidin concentration in supernatants of cultured respiratory mucosa cells [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cancer
  • Tuberculosis
  • Immunosuppressive therapeutics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by Fernando Sempertegui MD, 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