Matching vitamin D, glucosamine sulfate and omega-3 fatty acid placebo supplements. Supplements taken daily for 84 days (12 weeks).

Vitamin D (cholecalciferol, 4000 IU) with matching glucosamine sulfate and omega-3 fatty acid placebo supplements. Supplements taken daily for 84 days (12 weeks).

Vitamin D (cholecalciferol, 4000 IU) with glucosamine sulfate (1000 mg) and omega-3 fatty acids (eicosapentaenoic (EPA, 580 mg) and docosahexaenoic (DHA, 470 mg) acids). Supplements taken daily for 84 days (12 weeks).

Osteoarthritis, Knee

Vitamin D Supplementation

Placebo supplement for vitamin D (cholecalciferol), glucosamine sulfate, and omega-3 fatty acids. Supplement was taken orally every day for 84-days.

Placebo

Vitamin D (cholecalciferol). Supplement was taken orally every day for 84-days.

Vitamin D (cholecalciferol)

Glucosamine sulfate and omega-3 fatty acids supplement was taken orally every day for 84-days.

Glucosamine sulfate and omega-3 fatty acids

Vitamin D Supplementation in Knee Osteoarthritis

The Influence of Vitamin D Supplementation With and Without Glucosamine Sulfate and Omega-3 Fatty Acids in Patients With Osteoarthritis Symptoms

The influence of supplemental vitamin D on serum IL-10 concentration (pg/mL) in subjects with knee osteoarthritis.

The influence of supplemental vitamin D on single-leg peak isokinetic torque (Nm at 60 degrees per second) in subjects with knee osteoarthritis.

Patient reported pain and physical dysfunction (using the subsection questions in the WOMAC survey) will be reported by each subject.

Supplemental vitamin D influences serum cytokines (pg/mL) in subjects with knee OA

Supplemental vitamin D influences single leg peak isometric force (N) in subjects with knee osteoarthritis.

Supplemental vitamin D influences serum soluble cytokine receptors (sIL-1r, sIL-1r2, sIL-4r, sIL-6r, sTNFr1, and sTNFr2: pg/mL)

Supplemental vitamin D influences single leg peak output (Nm) in subjects with knee osteoarthritis.

Intermountain Health Care, Inc.

USANA Health Sciences

This study consists of a double-blind, placebo-controlled experimental design. Subjects will be randomly assigned to one of three groups: (#1) vitamin D (cholecalciferol, 4000 IU) with glucosamine sulfate (1000 mg) and omega-3 fatty acids (eicosapentaenoic (EPA, 580 mg) and docosahexaenoic (DHA, 470 mg) acids), (#2) vitamin D (cholecalciferol, 4000 IU) with matching glucosamine sulfate and omega-3 fatty acid placebo supplements, or (#3) matching vitamin D, glucosamine sulfate and omega-3 fatty acid placebo supplements. Supplements will be taken daily for 84 days (12 weeks). Groups will be permuted in random blocks of six.

The active substance used in the T-ChOS capsule formulation is a chitooligosaccharide blend.

Advanced Solid Tumors

T-ChOS 600 mg (two capsules, each 300 mg) daily in the morning 30 minutes before food.

T-ChOS

Herlev & Gentofte University Hospital, Denmark

Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

A Single Center, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

• time to reach maximum plasma concentration (tmax)

• area under the plasma concentration-time curve from zero to the last measurable time point (AUC0-t)

• area under the plasma concentration-time curve from zero to infinity (AUC)

• apparent plasma clearance following oral administration (CL/F)

Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.

ORR = complete response + partial response, according to RECIST 1.1

DCR = complete response + partial response + stable disease, according to RECIST 1.1

Serum YKL-40 during and following 4 weeks of treatment with T-ChOS

Serum CRP during and following 4 weeks of treatment with T-ChOS

Inna Chen, MD

Principal Investigator

Herlev Hospital

GENIS

3 ounces of mushrooms consumed daily for 4 weeks

6 ounces of mushrooms consumed daily for 4 weeks

3 Ounces of Mushrooms

6 Ounces of Mushrooms

Total

Sex: Female, Male

Region of Enrollment

Proliferation of γδ-T cells when cultured ex vivo in autologous serum. Values are expressed as a percent of CD3 cells, which means a percent of the total T cell population. Only T cells express CD3.

d glucosamine/neoplasms

Vitamin D Supplementation in Knee Osteoarthritis

Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

Immune Benefits From Mushroom Consumption

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