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

Completed · Not applicable · Has a placebo group

Conditions studied: Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT02876315

Run by

Oregon State University

People needed

42

Starts

2016-12-01

Expected to finish

2019-12-01

Last updated by the study team

2022-12-01

Who can join

Age: 55 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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
• 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)

Where it is running

• Oregon State University — Corvallis, Oregon, United States

Full record on ClinicalTrials.gov

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