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

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring innate immunity, elderly adults, multivitamin supplement, vitamin D, vitamin C, zinc Read More

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)
  • Thiazide diuretics
  • Calcium channel blockers
  • Phenobarbital or phenytoin or other anticonvulsants
  • Estrogen replacement therapy
  • Leukotriene receptor antagonists
  • Immunosuppressant/anti-rejection drugs
  • Oral corticosteroids