Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Rare Diseases

Inflammation

Osteoarthritis

Arthritis

Necrosis

Psoriasis

Autoimmune Diseases

Arthritis, Rheumatoid

Pain

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Chronic Graft Versus Host Disease

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Other Dietary Supplements

Vitamins

Vitamin D

Cholecalciferol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Omega 3 Fatty Acid

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.

Fish Oil

placebo pill

Karen H Costenbader, MD, MPH

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among VITAL participants and will examine whether vitamin D or fish oil have effects upon A) autoimmune disease incidence, B) biomarkers of systemic inflammation, and C) chronic knee pain. Blood samples at baseline and in follow-up will be collected in a randomly selected subcohort of 1500 individuals and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein, interleukin-6, and tumor necrosis factor-receptor 2. Approximately 1300 individuals with chronic, frequent knee pain will be followed with annual questionnaires to evaluate the effects of the supplements on chronic knee pain.

Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain

In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the IL-6 serum biomarker of systemic inflammation.

In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the CRP serum biomarker of systemic inflammation.

In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the TNFR2 serum biomarker of systemic inflammation.

All participants were followed for the development of new autoimmune diseases, including, but not limited to, rheumatoid arthritis, psoriasis, autoimmune thyroid disease, inflammatory bowel disease and polymyalgia rheumatica. The primary endpoint was all incident autoimmune disease confirmed by extensive medical record review. Participants self-reported all incident autoimmune diseases from baseline through follow-up. We used Cox proportional hazards models to test the effects of vitamin D and n-3 fatty acids upon autoimmune disease incidence.

We compared the separate main effects of vitamin D or n-3 fatty acid supplement assignment on AD incidence using Cox regression models. To account for randomization stratification and study design, we additionally adjusted for age, sex, self-reported race, and randomization to the other supplement. Person-time was counted until diagnosis of a new confirmed AD, death, or the end of the trial. We also test interactions between the two supplements

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain was the primary outcome on a scale of 0-100 with 100= worst pain.

Subsample of VITAL participants with chronic, frequent knee pain at trial baseline were followed with annual WOMAC questionnaires to test for change in severity of chronic knee pain in those taking Omega-3 fish oil (n-3 FA) supplements compared to those taking placebo and for those taking Vitamin D supplements compared to those taking placebo. We tested whether n-3 FA supplements and Vitamin D are associated with reduced levels of WOMAC knee pain at the end of the trial (comparing knee pain outcomes in those receiving supplements to placebo). We will also test whether there were multiplicative interactions between the two supplements for the outcome of knee pain severity by WOMAC-Pain index

Development of new autoimmune disease through observational follow-up after trial termination.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Brigham and Women's Hospital

Associate Physician

Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleeding, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash

Omega-3 FA Monitored safety cond'ns: GI bleeding; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping

Vitamin D3, one 2000 IU capsule/day

Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).

Active Vitamin D/ Active Omega-3 Fatty Acids

Vitamin D3, one 2000 IU capsule/day

Omega-3 fatty acids placebo, one capsule/day

Active Vitamin D/ Active Omega-3 Placebo

Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).

Vitamin D placebo, one capsule/day

Active Omega-3 Fatty Acids, Placebo Vitamin D

Omega-3 fatty acids placebo, one capsule/day

Vitamin D placebo, one capsule/day

Omega-3 Fatty Acids Placebo/ Placebo Vitamin D

ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids

ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day

ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids

PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids

PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day

PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids

Total

Age, Categorical

Age, Continuous

Female

Male

Sex/Gender, Customized

Non-Hispanic white

African American

Hispanic (not African American)

Asian/Pacific Islander

Native American/ Alaskan Native

Other/ unknown

Race/Ethnicity measured using different categories in systemic inflammation versus knee pain subcohorts.

Race/Ethnicity, Customized

United States

Region of Enrollment

In this 2x2 factorial design trial, the primary analyses were: all active vitamin D vs. all placebo vitamin D and all active omega-3 fatty acids vs. all placebo omega-3 fatty acids.

Karen Costenbader

Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.

Test for interaction between effect of vitamin D and effect of omega-3 fatty acids on IL-6 change from baseline to 1 year

Baseline ln (IL-6) pg/ml, geometric mean (95% Cl)

Year 1 ln (IL-6) pg/mL, geometric mean (95% CI)

Active Vitamin D

Placebo Vitamin D

Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).

Active n-3 FA

Omega-3 fatty acids placebo, one capsule/day

Placebo n-3 FA

Subsample of the VITAL trial participants at baseline and one year.

Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)

Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.

Baseline ln (hsCRP) mg/L, geometric mean (95% Cl)

Year 1 ln (hsCRP) mg/L, geometric mean (95% CI)

Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP)

Baseline ln (TNFR2) pg/ml, geometric mean (95% Cl)

Year 1 ln (TNFR2) pg/mL, geometric mean (95% CI)

Serum Levels of Biomarkers of Systemic Inflammation: Tumor Necrosis Factor-receptor 2 (TNFR2)

Test for multiplicative interaction between the effects of randomized treatment groups, vitamin D and n-3 fa on incidence of autoimmune disease.

All participants in VITAL followed for the development of new autoimmune diseases, including, but not limited to, rheumatoid arthritis, psoriasis, autoimmune thyroid disease, inflammatory bowel disease and polymyalgia rheumatica. Categorized by vitamin D (active/placebo) and n-3 (active/placebo)

Incident Autoimmune Diseases

Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.

We assessed for effect modification between vitamin D and N-3 FA and tested for other pre-specified interactions. We again used a repeated measures model with censoring for TKR. We adjusted for age, sex and N-3 FA treatment arm (in analyses in which N-3 FA treatment arm was not investigated as a potential modifier).

Active n3fa vs placebo n3fa among those on placebo vitamin D.

Vitamin D vs. vitamin D placebo among those on placebo omega-3 fatty acids- stratified analyses.

Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on active vitamin D.

Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on placebo vitamin D.

Baseline mean WOMAC Pain

Follow Up mean WOMAC pain

Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA) + Vitamin D3, one 2000 IU capsule/day or Vitamin D placebo, one capsule/day

Omega-3 fatty acids placebo, one capsule/day + Vitamin D3, one 2000 IU capsule/day or Vitamin D placebo, one capsule/day

Vitamin D3, one 2000 IU capsule/day + Omega 3 Omacor fatty acid, 1-g capsule/day or Omega-3 fatty acid placebo

Placebo vitamin D3, one 2000 IU capsule/day + Omega 3 Omacor fatty acid, 1-g capsule/day or Omega-3 fatty acid placebo

Subsample of the VITAL trial who reported chronic frequent knee pain prior to randomization.

Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA & Vitamin D

Incident Autoimmune Disease

Overall Study

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Acupuncture protocol 1：participants will receive treatment (acupuncture protocol 1, real acupuncture) twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes.

Acupuncture protocol 2：participants will receive treatment (acupuncture protocol 2, sham acupuncture) twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes. All participants will receive treatment twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes.

Disposable, single-use, sterilized needles made of stainless steel, 0.25 x 30 mm and 0.30 x 40/50mm (Wuxi Jiajian Medical Instrument. 251226 Wuxi, China) will be inserted to a depth of 15-35 mm in some acupoints. After getting the needle sensation (de qi), some acupoints will receive electrical stimulation and the others will receive manual stimulation. All participants will receive treatment twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes.

acupuncture protocol 1

Disposable, single-use, sterilized needles (0.20 x 20mm) made of stainless steel will be inserted to a depth of \<5 mm at non-acupoints without evoking the needle sensation (Deqi). Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture protocol 1 group. No manual stimulation of the needles will be performed.

Acupuncture protocol 2

Dongmei Huang, doctor

Low-frequency electroacupuncture (EA) can decrease serum 17-hydroxyprogesterone (17-OHP), androstenedione (A) and testosterone (T)of young women with polycystic ovary syndrome in the Human chorionic gonadotrophin (HCG) stimulation test ，also，we hypothesize that EA is more efficiency in improving ovulation rate and menstrual cycle than sham acupuncture.

First, patients will be recruited according to the inclusion criteria and exclusion criteria.

Second, baseline measurements (including menstrual frequency,human chorionic gonadotropin (HCG) stimulation test,physical examination,trans-abdomen ultrasound of the uterus and ovaries, serum levels of sex hormone steroids) will be taken.

Third, each patient will receive 32 sessions of acupuncture in 16 weeks, twice a week.

Last, the above baseline measurements will be taken again as soon as the treatment is finished and menstrual frequency will be recorded during the 12 weeks of follow-up after the treatment.

Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome

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Human chorionic gonadotrophin (HCG) stimulation test: Both at baseline and in one week after the treatment, the patients will receive an intramuscular injection of 5000 IU HCG, and 24 h and 48 h later, serum 17-hydroxyprogesterone (17-OHP), androstenedione (A) and testosterone (T) of the patients will be detected.

Serum levels of sex hormone steroids including blood follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrogen, progesterone, prolactin and total testosterone will be evaluated at baseline and 16 weeks. Oral glucose tolerance test (OGTT) and insulin releasing test will be performed at baseline and 16 weeks. Serum levels of leptin, adiponectin, resistin, adrenal cortical hormone and beta endorphin will be examined at baseline and 16 weeks later.

The uterine dimensions, endometrial thickness and echo type, other uterine abnormalities, presence and size of leiomyoma, uterine artery blood flow parameters (pulsation index, resistance index, Shrinkage value / Diastolic value) will be obtained through trans-abdomen ultrasound at baseline and 16 weeks. The ovarian size in three dimensions, the size of the largest ovarian follicle/cyst and size of every follicle with a mean diameter greater than 10 mm, and total antral follicle (small follicles with mean diameter \< 10 mm) count of each ovary; ovarian artery blood flow parameters will be observed through trans-abdomen ultrasound at baseline and 16 weeks later.

Physical examination including vital signs, height, weight, hip and waist measurements, BMI and assessment of hirsutism by Ferriman-Gallwey score and acne standard acne lesion counts will be performed at baseline and 16 weeks.

Adverse events happened during 16-week treatment period and 12-week follow-up will be recorded and classified. Unless otherwise formal requirements, each report about the detail and summary of adverse event to data safety supervision and the commission will be reported by double blind way.

The menstruation characteristics including menstrual cycle, duration and amount of the past 4 months and during the treatment period will be recorded. Menstrual frequency was calculated by dividing the number of menstrual bleeding by 4.

serum levels of AD, NE,5-HT and GABA between two groups both at baseline and after the treatment.

Heilongjiang University of Chinese Medicine

Hubei College of Traditional Chinese Medicine

The University of Hong Kong

Huazhong University of Science and Technology

Department of Integrated Traditional Chinese and Western Medicine Tongji hospital

Antineoplastic Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Immune checkpoint inhibitor

Carine A Bellera, PhD

The objective of this research work is two-fold: (i) to conduct a systematic literature review to identify surrogate endpoints in this specific drug class (review registered in the PROSPERO database) and (ii) to assess the surrogate properties of candidate surrogate endpoints in the specific context of melanoma cancer.

Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)

Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials

Time from randomization to progression or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain	NCT01351805	Autoimmune Dise... Systemic Inflam... Knee Pain Chron... Osteoarthritis Rheumatoid Arth...	Fish Oil Vitamin D placebo pill	50 Years -	Brigham and Women's Hospital
Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome	NCT01812161	Polycystic Ovar...	acupuncture pro... Acupuncture pro...	18 Years - 28 Years	Huazhong University of Science and Technology
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)	NCT03963518	Cancer Treated ...	Immune checkpoi...	18 Years -	Institut Bergonié
Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome	NCT01812161	Polycystic Ovar...	acupuncture pro... Acupuncture pro...	18 Years - 28 Years	Huazhong University of Science and Technology

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Spots Global Cancer Trial Database for trial

Every month we try and update this database with for trial cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for trial cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.