The Effect of Combinatorial Nutritional Supplementation on Immune Function in Healthy Older Adults
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

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.
    

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.
    

Intervention name(s): Redoxon VI; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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; Ingredients: Microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, hydroxypropylcellulose hypromellose, titanium dioxide, microcrystalline cellulose, iron oxide yellow, sodium croscarmellose, and talc
Other intervention name(s): Redoxon Vita Immune
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: innate immunity; elderly adults; multivitamin supplement; vitamin D; vitamin C; zinc