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The Effect of Combinatorial Nutritional Supplementation on Immune Function in Healthy Older Adults

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ClinicalTrials.gov Identifier: NCT02876315
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Adrian F. Gombart, Oregon State University

Brief Summary:
Many older adults do not get enough zinc, vitamin C and vitamin D, and this can be related to decreased ability to fight infection. The purpose of this research study is to determine if taking a multivitamin/mineral supplement every day for 12 weeks will increase the ability of immune cells in blood to kill bacteria.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Redoxon VI Dietary Supplement: placebo Not Applicable

Detailed Description:

Vitamins C and D and the mineral zinc are each considered immune modulating micronutrients, but their specific effects on the immune system, especially when used in combination, is relatively unknown. Deficiency in each of these micronutrients is frequently observed in aging adults and may contribute to age-related declines in immune status. Based on prior published studies, the investigators hypothesize that supplementation of older adults with a combination of vitamin C, vitamin D, and zinc will increase the innate ability of neutrophils to kill invading bacteria through a variety of mechanisms, including increased phagocytosis, antimicrobial peptide expression and changes in reactive oxygen species (ROS) production.

Therefore, this study is designed to investigate the effects of Redoxon VI, a supplement consisting of a combination of vitamin C, vitamin D, and zinc on functional markers of the immune system of healthy, older adults when compared to a matched placebo. To accomplish this, the investigators will recruit 40 healthy adults between the ages of 60 and 75 and randomize them to either Redoxon VI or an identical, inactive placebo control supplement to be taken twice a day for 12 weeks.

Since neutrophil-mediated killing is a crucial defense against Staphylococcus aureus infection that declines with age, it will serve as a primary outcome in this study. Using blood collected from individuals before and after supplementation, the investigators will measure the ability of neutrophils to clear S. aureus cells, and compare the killing activity in those individuals receiving the vitamin and mineral supplement to those receiving the placebo. The investigators will confirm these changes in immune cell function by also measuring phagocytic activity in neutrophils, as well as their ability to produce ROS.

As secondary measures of immune function, the investigators will also determine circulating levels of neutrophils, monocytes and lymphocytes, measure cathelicidin antimicrobial peptide (also known as hCAP18/LL-37) levels, and determine changes in circulating levels of inflammatory cytokines.

Based on previous studies, the investigators expect that any increase in functional immune status will correspond to changes in vitamins C, D and zinc status in these individuals. The investigators expect the results from this study to provide the foundation for future studies investigating combinations of supplements on immune function and more extensive studies using these micronutrients to restore declines in immune function observed in older adults.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Combinatorial Nutritional Supplementation on Immune Function in Healthy Older Adults
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Redoxon VI
2 film coated tablets Redoxon VI oral intake daily for 12 weeks
Dietary Supplement: Redoxon VI

Each tablet contains:

Vitamin C (500mg) Vitamin A (1167IU) Vitamin B6 (3.3mg) Vitamin B12 4.8µg) Vitamin D (200IU) Vitamin E (22.5mg) Folic Acid (200µg) Zinc (5mg) Selenium (55µg) Copper (450µg) Iron (2.5mg)

Other ingredients: Microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, hydroxypropylcellulose hypromellose, titanium dioxide, microcrystalline cellulose, iron oxide yellow, sodium croscarmellose, and talc

Other Name: Redoxon Vita Immune

Placebo Comparator: Placebo
2 film coated tablets placebo oral intake daily for 12 weeks
Dietary Supplement: placebo
Ingredients: Microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, hydroxypropylcellulose hypromellose, titanium dioxide, microcrystalline cellulose, iron oxide yellow, sodium croscarmellose, and talc




Primary Outcome Measures :
  1. S. aureus clearance from whole blood [ Time Frame: 12 weeks ]
    Determine the clearance of S. aureus by whole blood from individuals before and after treatment with Redoxon VI or placebo using a whole blood killing functional assay


Secondary Outcome Measures :
  1. Determine phagocytic activity of neutrophils by measuring uptake of fluorescently labeled Escherichia coli using flow cytometry [ Time Frame: 12 weeks ]
    Determine phagocytic activity of neutrophils before and after treatment. The investigators will measure phagocytic activity by quantifying the uptake of pHrodoTM Red-labeled Escherichia coli (LifeTechnologies, Carlsbad, CA) by fluorescence activated cell sorting (FACS). The amount of bacteria taken-up by the neutrophils will be determined by mean fluorescence of all cells.

  2. Total ROS generation by neutrophils [ Time Frame: 12 weeks ]
    Determine total ROS generation by neutrophils before and after treatment.

  3. Number of neutrophils, monocytes and lymphocytes [ Time Frame: 12 weeks ]
    Determine the number of circulating neutrophils, monocytes and lymphocytes in blood of individuals before and after treatment.

  4. hCAP18 levels in neutrophils, monocytes and serum [ Time Frame: 12 weeks ]
    Determine hCAP18 levels in neutrophils, monocytes and sera from individuals before and after treatment.

  5. Serum levels of inflammatory cytokines [ Time Frame: 12 weeks ]
    Determine levels of inflammatory cytokines in sera from individuals before and after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Serum vitamin D level 25-50 nmol/L (10-20 ng/ml), inclusive
  • Willing to limit intake of salmon, herring and sardines to one 4-ounce serving per week for 3 weeks prior to and throughout the study.
  • Willing to limit intake of oysters, shellfish, liver, beef, lamb and poultry dark meat to one 4-ounce serving per week for 3 weeks prior to and throughout the study.
  • Willing to limit intake of citrus fruits and citrus fruit juices to 2 servings per day during the study for 3 weeks prior to and throughout the study.
  • Willing to stop taking multivitamins, supplements containing zinc, vitamins C and D, and food/beverage products supplemented with zinc and vitamins C and D for 3 weeks prior to and throughout the study.

Exclusion Criteria:

  • Usual dietary intake of zinc >15 mg/day (as determined in Telephone Screening Script)
  • Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past three months or plans to smoke during the study.
  • Have undergone a surgical procedure within the past two months or expect a surgical procedure in the next four months.
  • Regularly consume more than two alcoholic drinks a day.
  • Have participated in another clinical study within the past two months.
  • Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis) or UV tanning.
  • Have a significant acute or chronic illness such as cardiovascular disease, kidney or liver disease, diabetes, thyroid or parathyroid disorder, history of cancer less than five years.
  • Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedure (e.g. cholecystectomy) or disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis)
  • Stage II hypertension (either systolic blood pressure > 159 mm Hg or diastolic blood pressure > 99 mm Hg)
  • BMI < 18.5 or > 29.9
  • Diagnosis of hypervitaminosis A, hypervitaminosis D, or hypercalcemia
  • Have received an organ or tissue transplant
  • Have eczema, atopic dermatitis, or psoriasis
  • Have or have had allergy to medications or foods, seasonal allergies or allergic asthma after age 18 (childhood asthma/allergies not exclusionary)
  • Diagnosis of an autoimmune disorder (e.g. lupus, rheumatoid arthritis, multiple sclerosis, etc.) or HIV positive status.
  • Currently taking or using any of the following medications:

    • Topical medications containing retinoids
    • Desferioxamine
    • Disulfiram
    • Warfarin
    • Vitamin D analogs
    • Vitamin A analogs
    • Cholestyramine
    • Orlistat
    • Mineral oil (oral intake)
    • Thiazide diuretics
    • Calcium channel blockers
    • Phenobarbital or phenytoin or other anticonvulsants
    • Estrogen replacement therapy
    • Leukotriene receptor antagonists
    • Immunosuppressant/anti-rejection drugs
    • Oral corticosteroids

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): NCT02876315


Locations
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United States, Oregon
Oregon State University
Corvallis, Oregon, United States, 97331
Sponsors and Collaborators
Oregon State University
Investigators
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Principal Investigator: Adrian F Gombart, PhD Principal Investigator

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Responsible Party: Adrian F. Gombart, Associate Professor, Department of Biochemistry and Biophysics, Oregon State University
ClinicalTrials.gov Identifier: NCT02876315     History of Changes
Other Study ID Numbers: LPI-7531
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adrian F. Gombart, Oregon State University:
innate immunity
elderly adults
multivitamin supplement
vitamin D
vitamin C
zinc
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs