NCT02876315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

August 11, 2016

Last Update Submit

November 29, 2022

Conditions

Vitamin D Deficiency

Keywords

innate immunityelderly adultsmultivitamin supplementvitamin Dvitamin Czinc

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (5)

  • Determine phagocytic activity of neutrophils by measuring uptake of fluorescently labeled Escherichia coli using flow cytometry

    12 weeks

  • Total ROS generation by neutrophils

    12 weeks

  • Number of neutrophils, monocytes and lymphocytes

    12 weeks

  • hCAP18 levels in neutrophils, monocytes and serum

    12 weeks

  • Serum levels of inflammatory cytokines

    12 weeks

Study Arms (2)

Redoxon VI

EXPERIMENTAL

2 film coated tablets Redoxon VI oral intake daily for 12 weeks

Dietary Supplement: Redoxon VI

Placebo

PLACEBO COMPARATOR

2 film coated tablets placebo oral intake daily for 12 weeks

Dietary Supplement: placebo

Interventions

Redoxon VIDIETARY_SUPPLEMENT

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

Also known as: Redoxon Vita Immune
Redoxon VI
placeboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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:
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Related Publications (1)

  • 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.

    PMID: 32823974DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Adrian F Gombart, PhD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Biochemistry and Biophysics

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 23, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2019

Study Completion

December 1, 2019

Last Updated

December 1, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)