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.

Use TGF to treat osteoarthritis of the knee, 5g/time, 3 times a day, for 12 weeks.

Use TGFP to treat osteoarthritis of the knee, 5g/time, 3 times a day, for 12 weeks.

TGF is a powder formulation of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..

TGFP is 1/20 concentration of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..

TGFP

The Efficacy of TGF for Treating Osteoarthritis of the Knee

The Efficacy of TGF for Treating Osteoarthritis of the Knee: A Randomized Double-blind Controlled Trial

This scale is the VAS version, 3.1 and divided into three sub-scales -- pain, stiffness and function. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing. Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item has 0-100 mm to evaluate the status and the higher values represent a worse outcome. These three sub-scales were summed to a total score (0-2400 mm).

To evaluate the status of knee pain when check point. Using 0-100 mm scale is to evaluate knee pain by visual analogue scale. "0" is no pain and "100" is the worst pain that subjects had experienced before. The subject gives the value under the moment of check point.

To evaluate the dosage of Celebrex when check point

knee joint that associated with this study

For evaluating the constitution. This scale (Constitution in Chinese Medicine Questionnaire) includes nine constitutions and each constitution has 6-8 items that used 1-5 points to evaluate the degree. "1" means "better" and "5" means "worse". The transformed points is equal to [(original points - the number of items)/(the number of itmes*4) ]*100.

For evaluating the quality of life. This scale is "World Health Organization Quality of Life - BREF". It contains 4 domains (Physical health, Psychological, Social relationships and Environment) and 26 items ("1" means "worse" and "5" means "better"). This scale used the following steps to calculate the transformed points: 1.Check all 26 items from assessment have a range of 1-5, 2.Reverse 3 negatively phrased items, 3.Compute domain scores, 4. Delete cases with >20% missing data, 5.Check domain scores.

For evaluating the status of inflammation. Erythrocyte Sedimentation Rate (ESR) actually measures the rate of fall (sedimentation) of erythrocytes (red blood cells) in a sample of blood that has been placed into a tube. Results are reported as the millimeters of clear fluid (plasma) that are present at the top portion of the tube after one hour. The higher value means more inflammation.

This study uses ELISA kit to measure the concentraion (pg/ml) of C-Telopeptide of Type II Collagen (CTX-II) .

This study uses ELISA kit to measure the concentraion (ng/ml) of Cartilage Oligomeric Matrix Protein (COMP) .

This study uses ELISA kit to measure the concentraion (ng/ml) of Osteocalcin .

This study uses ELISA kit to measure the concentraion (pg/ml) of Leptin.

This study uses ELISA kit to measure the concentraion (ng/ml) of interleukin-1 (IL-1).

This study uses ELISA kit to measure the concentraion (ng/ml) of interleukin-6 (IL-6).

This study uses ELISA kit to measure the concentraion (ng/ml) of matrix metalloproteinase-3 (MMP-3).

This study uses ELISA kit to measure the concentraion (pg/ml) of matrix metalloproteinase-13 (MMP-13).

This study uses ELISA kit to measure the concentraion (ng/ml) of a disintegrin and metalloproteinase with thrombospondin motifs-4 (ADAMTS-4).

This study uses ELISA kit to measure the concentraion (ng/ml) of Transglutaminase 2 (TG-2).

The metabolite of the drugs. This measurement used LC-MS to get the molecular weight of Chinese herbal metabolites form blood, urine and synovial fluid. This method can help to identify the active substance from the formula (TGF). Here, we cannot to know the exactly active substance that we will get.

the expression of mRNA in PGC-1α by quantitative polymerase chain reaction

the expression of mRNA in NRF1 by quantitative polymerase chain reaction

the expression of mRNA in mtTFA by quantitative polymerase chain reaction

the expression of protein in PGC-1α by Western blotting

the expression of protein in NRF1 by Western blotting

the expression of protein in mtTFA by Western blotting

anti-oxidant capacity by OxiSelectTM Trolox Equivalent Antioxidant Capacity (TEAC) Assay Kit (ABTS)

For evaluating the status of inflammation. High-sensitivity C-reactive Protein is a protein that increases in the blood with inflammation and infection as well as following a heart attack, surgery, or trauma. Thus, it is one of several proteins that are often referred to as acute phase reactants. The high-sensitivity CRP test measures low levels of CRP in the blood to identify low levels of inflammation that are associated with risk of developing cardiovascular disease (CVD).

glucosamine sulfate/neoplasms

Vitamin D Supplementation in Knee Osteoarthritis

The Efficacy of TGF for Treating Osteoarthritis of the Knee

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