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
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Dietary Supplement: Redoxon VI Dietary Supplement: placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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
- 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.
- Total ROS generation by neutrophils [ Time Frame: 12 weeks ]Determine total ROS generation by neutrophils before and after treatment.
- 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.
- 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.
- Serum levels of inflammatory cytokines [ Time Frame: 12 weeks ]Determine levels of inflammatory cytokines in sera from individuals before and after treatment.
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
|United States, Oregon|
|Oregon State University|
|Corvallis, Oregon, United States, 97331|
|Principal Investigator:||Adrian F Gombart, PhD||Principal Investigator|