Vitamin D DeficiencyNCT02876315
The Effect of Combinatorial Nutritional Supplementation on Immune Function in Healthy Older Adults
A study testing Redoxon VI in people with Vitamin D Deficiency, run by Oregon State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Redoxon VI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Redoxon VI, placebo
- Keywords
- innate immunity, elderly adults, multivitamin supplement, vitamin D, vitamin C, zinc
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redoxon VIDietary supplement
Also called Redoxon Vita Immune
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
placeboDietary supplement
Ingredients: Microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, hydroxypropylcellulose hypromellose, titanium dioxide, microcrystalline cellulose, iron oxide yellow, sodium croscarmellose, and talc
| Study group | Role | What they receive |
|---|---|---|
| Redoxon VI | Experimental | 2 film coated tablets Redoxon VI oral intake daily for 12 weeks Receives: Dietary Supplement: Redoxon VI |
| Placebo | Placebo comparator | 2 film coated tablets placebo oral intake daily for 12 weeks Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
S. aureus clearance from whole blood
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
Measured: 12 weeks
Secondary outcomes (5)
Determine phagocytic activity of neutrophils by measuring uptake of fluorescently labeled Escherichia coli using flow cytometry
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.
Measured: 12 weeks
Total ROS generation by neutrophils
Determine total ROS generation by neutrophils before and after treatment.
Measured: 12 weeks
Number of neutrophils, monocytes and lymphocytes
Determine the number of circulating neutrophils, monocytes and lymphocytes in blood of individuals before and after treatment.
Measured: 12 weeks
hCAP18 levels in neutrophils, monocytes and serum
Determine hCAP18 levels in neutrophils, monocytes and sera from individuals before and after treatment.
Measured: 12 weeks
Serum levels of inflammatory cytokines
Determine levels of inflammatory cytokines in sera from individuals before and after treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian F. Gombart, Oregon State University
- Investigators
- Adrian F Gombart, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876315
- Sponsor's protocol ID
- LPI-7531
- Status last verified
- Nov 2022
- First submitted
- 11 Aug 2016
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fantacone ML, Lowry MB, Uesugi SL, Michels AJ, Choi J, Leonard SW, Gombart SK, Gombart JS, Bobe G, Gombart AF. The Effect of a Multivitamin and Mineral Supplement on Immune Function in Healthy Older Adults: A Double-Blind, Randomized, Controlled Trial. Nutrients. 2020 Aug 14;12(8):2447. doi: 10.3390/nu12082447.
PubMed 32823974
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combinatorial Nutritional Supplementation on Immune Function in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT02876315
- Acronym / sponsor ID
- LPI-7531
- Conditions
- Vitamin D Deficiency
- Keywords
- innate immunity, elderly adults, multivitamin supplement, vitamin D, vitamin C, zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Redoxon VI | Experimental | Dietary Supplement: Redoxon VI2 film coated tablets Redoxon VI oral intake daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: placebo2 film coated tablets placebo oral intake daily for 12 weeks |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redoxon VIAlso: Redoxon Vita ImmuneEach 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 | Dietary supplement | Redoxon VI |
| placeboIngredients: Microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, hydroxypropylcellulose hypromellose, titanium dioxide, microcrystalline cellulose, iron oxide yellow, sodium croscarmellose, and talc | Dietary supplement | Placebo |
Primary outcome
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
5 secondary outcomes
Determine phagocytic activity of neutrophils by measuring uptake of fluorescently labeled Escherichia coli using flow cytometry
Time frame: 12 weeks
Total ROS generation by neutrophils
Time frame: 12 weeks
Number of neutrophils, monocytes and lymphocytes
Time frame: 12 weeks
hCAP18 levels in neutrophils, monocytes and serum
Time frame: 12 weeks
Serum levels of inflammatory cytokines
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Derived from this study: PubMed 32823974Fantacone ML, Lowry MB, Uesugi SL, Michels AJ, Choi J, Leonard SW, Gombart SK, Gombart JS, Bobe G, Gombart AF. The Effect of a Multivitamin and Mineral Supplement on Immune Function in Healthy Older Adults: A Double-Blind, Randomized, Controlled Trial. Nutrients. 2020 Aug 14;12(8):2447. doi: 10.3390/nu12082447.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian F Gombart, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redoxon VI in people with Vitamin D Deficiency, run by Oregon State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S. aureus clearance from whole blood (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02876315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.