Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Gland and Hormone Related Diseases

Breast Neoplasms

Thyroid Diseases

Breast Diseases

Skin Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Herbal and Botanical

Insulin

Insulin, Globin Zinc

Hormones

Estrogens

Mitogens

Phytoestrogens

Soy Bean

Arm 1 5 g/d Seaweed for 6 wk, then 5 g/d Seaweed and Soy Protein for 1 wk

Arm 2 5 g/d Placebo for 6 wk, then 5 g/d Placebo and Soy Protein for 1 wk

5 g/d Seaweed for 6 wks, followed by 5 g/d Seaweed + Soy Protein for 1 wk

Seaweed and Soy Protein

5 g/d Placebo for 6 wks, followed by 5 g/d Placebo + Soy Protein for 1 wk

Placebo and Soy Protein

Jane Teas, Ph.D.

Japanese postmenopausal women in Japan have about one ninth the rate of American postmenopausal women. Rates of breast cancer double even after just ten years among Japanese women who migrate to the US. Diet is thought to be an important factor, and the investigators were interested in whether dietary seaweed, with and without soy supplements, could influence known biomarkers of breast cancer risk in American women.

33 healthy postmenopausal women were randomized to 6 wk seaweed then 1 wk seaweed plus soy or 6 wk placebo then 1 wk placebo plus soy. Blood and urine samples were collected at the end of each treatment period and analyzed for estrogen, homocysteine, antioxidants, insulin-like growth factors and thyroid hormones. Urine was analyzed for phytoestrogens and iodine.

Brown Seaweed as a Breast Cancer Preventive

6 wk seaweed followed by 1 wk seaweed plus soy; Or 6 wk placebo followed by 1 wk soy 3 wk washout period then crossover to alternate arm

6 wk seaweed then 1 wk seaweed plus soy; OR 6 wk placebo then 1 wk soy 3 wk washout period, then crossover to alternate arm

6 wks seaweed followed by 1 wk seaweed plus soy OR 6 wk placebo followed by 1 wk soy 3 wk washout period, then crossover to alternate arm

6 wk seaweed then 1 wk seaweed plus soy OR 6 wk placebo then 1 wk soy plus placebo 3 wk washout then crossover to alternate arm

Susan G. Komen Breast Cancer Foundation

University of South Carolina

Professor

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Inflammation

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

Natriuretic Agents

Reproductive Control Agents

Antineoplastic Agents

Androgens

Metformin

Spironolactone

Pioglitazone

Complement System Proteins

Ethinyl Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Androgen Antagonists

2,4-thiazolidinedione

Cyproterone Acetate

Cyproterone

Mineralocorticoid Receptor Antagonists

Mineralocorticoids

Hormone Antagonists

Diuretics

Diuretics, Potassium Sparing

Contraceptive Agents

Contraceptive Agents, Male

Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily

Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily

Cyproterone compound + Spironolactone

Mesbah Shams, MD

Gholamhossein R Omrani, MD

The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation \[serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)\] levels.

Polycystic ovary syndrome (PCOS) is estimated to affect up to10% of women of reproductive age, making it one of the most common endocrine disorders in this population. PCOS is associated with a broad range of adverse sequel, including hypertension, dyslipidemia, insulin resistance, hyperandrogenaemia, gestational and type 2 diabetes,which ultimately increase the cardiovascular morbidity in these patients. Also PCOS is increasingly recognized as a component of the metabolic syndrome. Management depends on symptoms or the source of androgen excess. Several treatment options are available, which allows for an individualized approach. Spironolactone is the safest potent available antiandrogen. It is effective in lowering the hirsutism score by approximately one third, although considerable individual variations exist. Other antiandrogens used to treat hirsutism and hirsutism equivalents include cyproterone acetate that has weak antiglucocorticoid effects. Metformin and thiazolidinediones, are promising adjuncts for treating PCOS. Although both of them increase insulin sensitivity, but their mechanism of action differ.

Serum complement, homocysteine and C-reactive protein (CRP) levels have been reported to be linked with insulin resistance.

The investigators want to measure serum complement, homocysteine and hs-CRP levels in patients with PCOS before and after three-month course of treatment with Cyproterone compound-Spironolactone (CC-S), metformin (M) and pioglitazone (P).

Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS

Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)

Serum concentration of a component of complement cascade: C3

Serum concentration of a component of complement cascade: C4

Serum concentration of high-sensitive C-reactive protein (hs-CRP)

Serum concentration of total Testosterone

Serum concentration of Dehydroepiandrosterone sulfate

Serum concentration of follicle stimulating hormone

Serum concentration of luteinizing hormone

Shiraz University of Medical Sciences

Associate professor of internal medicine and endocrinology

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Nervous System Diseases

Wounds and Injuries

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Myocardial Infarction

Infarction

Diabetes Mellitus

Stroke

Fractures, Bone

Osteoporotic Fractures

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Ischemia

Necrosis

Heart Diseases

Micronutrients

Hematinics

Vitamins

Vitamin B 6

Pyridoxal

Pyridoxine

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Pyridoxal Phosphate

Folinic Acid

Vitamin B6

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Participants in NORVIT and WENBIT allocated to daily oral treatment with folic acid 0.8 mg and vitamin B12 0.4 mg

Participants in NORVIT and WENBIT allocated to daily oral treatment with folic acid 0.8 mg, vitamin B12 0.4 mg and B6 40 mg.

Participants in NORVIT and WENBIT allocated to daily oral treatment with vitamin B6 40 mg.

Participants in NORVIT and WENBIT allocated to daily oral treatment with placebo

Ottar Nygård, MD, PhD

Two large homocysteine-lowering B-vitamin intervention trials have been performed in Norway during the period 1998 to 2005, NORVIT and WENBIT. The main objective in these trials was to study the clinical effects of homocysteine-lowering therapy with folic acid and vitamin B12 in patients with established coronary artery disease. Follow-up was terminated for NORVIT on Marc 31st 2004 and for WENBIT October 5th 2005, and none of the two trials proved any protective effect of the B-vitamin intervention on cardiovascular outcomes.

There is so far no data on possible long-term effects following years of such B-vitamin treatment.

Thus, the main objective of the combinded NORVIT-WENBIT study will will be to evaluate the long-term effect of the B-vitamin intervention on incident life-style diseases including cardiovascular disease, diabetes, osteoporotic fractures and cancer.

A secondary object will be the identification of risk phenotypes or genotypes, and if such risk associations are midified by the B-vitamin intervention

The "homocysteine-hypothesis" of vascular disease has attracted considerable interest, as total plasma homocysteine levels can be easily lowered by folic acid and vitamin B12, raising the prospect that cardiovascular disease could be lowered by such B-vitamin supplementation.

Two large B-vitamin intervention trials have been performed in Norway during the period 1998 to 2005, NORVIT and WENBIT, both registered at ClinicalTrials.gov, identifiers NCT00266487 and NCT00354081, respectively. The main objective in these trials was to study the effects of homocysteine-lowering therapy with folic acid and vitamin B12 to reduce the risk of cardiovascular events in patients with established coronary artery disease. The B-vitamin intervention, which included vitamin B6 in a 2x2 factorial design, was identical in the two trials. Follow-up was terminated for NORVIT on March 31st 2004 and for WENBIT October 5th 2005. Results from the NORVIT trial was published April 2006 {Bonaa, 2006} and preliminary results from the WENBIT trial were presented at the annual congress of the European Society of Cardiology September 4th 2007 {Zegers, 2007}. The WENBIT trial is completed and submitted for publication early in year 2008.

So far, none of the B-vitamin intervention trials have shown any statistically significant favourable effect of homocysteine-lowering therapy with folic acid with or without concomitant vitamin B12 on cardiovascular events {Bazzano, 2006}. In NORVIT there was even a trend towards an increased risk of cardiovascular events (myocardial infarctions) in patients receiving the combination of folic acid, vitamin B12 and vitamin B6. This trend was not observed in WENBIT. However, the treatment with folic acid / B12 was associated With a more rapid progression of angiographic coronary atenoses {Løland, 2010}. Thus, the "homocysteine-hypothesis" of vascular disease has been attenuated through the emergence of these negative trial results, whereas a potential harmful effect of the B-vitamin intervention has been revealed.

There is so far no data on possible long-term effects following years of B-vitamin supplementation. By combining analyses and follow-up in the NORVIT and WENBIT cohorts, we will probably have some more answers both considering possible subgroup and long-term effects of the B-vitamin intervention.

Current data indicate that folate prevents cancer, especially breast and colorectal cancer. However, during the last few years several reports have challenged this assumption. Swedish observational studies found increased risk of colorectal cancer at high blood folate levels {Van Guelpen, 2006} and increased risk of prostate cancer at high levels of folate and vitamin B12 {Hultdin, 2005}. In a randomised trial with folic acid versus placebo to prevent colorectal adenomas, one found increased risk of cancer in the group receiving folic acid, especially of prostate cancer {Cole, 2007}. In a long-term follow-up of women taking high doses of folic acid throughout pregnancy one found a doubled risk of deaths attributable to breast cancer {Charles, 2004}. Recently it has been hypothesized that the implementation of folic acid fortification of foods may have been wholly or partly responsible for the observed increase in colorectal cancer rates in the USA and Canada in the mid to late 1990s {Mason, 2007}. This has led to new hypotheses that folate may prevent carcinogenesis but may enhance the growth of established cancer cells {Ulrich, 2007}. The question of possible adverse effects of folic acid supplementation will be of major importance when public health administrations decide whether to implement or enhance programs folic acid fortification of foods.

The effect of the B-vitamin intervention will also be studied in relation to other life-style diseases like diabetes and osteoprosis.

Additionally, the combined NORVIT-WENBIT cohort will used for observational studies evaluating new risk phenotypes or genotypes and their potential effect modification by the B-vitamin interventions.

NORVIT and WENBIT - Long-term Follow-up

Combined Analyses and Long-term Follow-up in the Two Norwegian Homocysteine-Lowering B-Vitamin Trials NORVIT and WENBIT

University of Tromso

Norwegian Foundation for Health and Rehabilitation

Haukeland University Hospital

MD, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brown Seaweed as a Breast Cancer Preventive	NCT01204957	Breast Cancer	Seaweed and Soy... Placebo and Soy...	18 Years - 80 Years	University of South Carolina
Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS	NCT02689843	Polycystic Ovar...	Cyproterone com... Metformin Pioglitazone	18 Years - 35 Years	Shiraz University of Medical Sciences
NORVIT and WENBIT - Long-term Follow-up	NCT00671346	Cancer Myocardial Infa... Cerebrovascular...		27 Years - 86 Years	Haukeland University Hospital
NORVIT and WENBIT - Long-term Follow-up	NCT00671346	Cancer Myocardial Infa... Cerebrovascular...		27 Years - 86 Years	Haukeland University Hospital
NORVIT and WENBIT - Long-term Follow-up	NCT00671346	Cancer Myocardial Infa... Cerebrovascular...		27 Years - 86 Years	Haukeland University Hospital
Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS	NCT02689843	Polycystic Ovar...	Cyproterone com... Metformin Pioglitazone	18 Years - 35 Years	Shiraz University of Medical Sciences

Spots Global Cancer Trial Database for homocysteine

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