Three 30 mg capsules once daily, self-administered for 6 months.
Curcumin is a nutraceutical, which are products isolated or purified from foods. The rhizomes of the plant Curcuma longa produces turmeric, a spice commonly used in Indian cuisine. Turmeric is comprised of three curcuminoids, of which curcumin is the most abundant. Curcumin is a polyphenol molecule that has been investigated for anti-inflammatory and anti-neoplastic properties since the 1970s.

Three 30 mg capsules taken once daily, self-administered for 6 months.
Placebo capsules are identical to the curcumin capsules in color, taste, smell, size and shape.

Chronic Kidney Disease

Micro-particle Curcumin

Looks, smells, tastes and feels exactly like the Curcumin capsules.

Placebo

Population Health Research Institute

Kidney Clinical Care Unit

University Hospital

Victoria Hospital

Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease

Albuminuria will be measured using urinary albumin-to-creatinine ratio from first morning urine samples. At each visit (pre-randomization, and 3- and 6-months post-randomization), urinary albumin-to-creatinine ratio is measured on two consecutive days and the average of the two values will be computed. The average of the two values will be log-transformed using the natural logarithm. Albuminuria is the cardinal manifestation of a malfunctioning filtration barrier and the spillage of albumin into renal tubules is thought to be toxic to tubular cells, resulting in further kidney damage. Therefore, in the current understanding, albuminuria is both a marker and a mediator of kidney damage. Reduction of albuminuria has repeatedly been associated with improved renal outcomes. Leaders in the field of nephrology recommend that albuminuria be used as a valuable predictor of response to therapy for the prevention of kidney failure.

eGFR will be calculated using the CKD-EPI formula. The investigators will estimate the between-group difference in change in eGFR (6-month eGFR minus baseline eGFR), expressed in mL/min per 1.73m2, using linear regression.

The investigators will summarize the percentage of glycated hemoglobin pre-randomization and 6-months post-randomization and will present the between-group difference in change in percentage of glycated hemoglobin (6-month value minus pre-randomization value) among patients with diabetes mellitus.

The investigators will report on the outcome of progressive CKD, ESRD, and death, first as a composite outcome, and then as separate components. ESRD will be defined as an eGFR <15 mL/min/1.73 m2 or the initiation of renal replacement therapy, which includes chronic dialysis or transplantation; progressive CKD will be defined as an eGFR loss of ≥ 30% (anytime during follow-up from the pre-randomization baseline value) or ESRD. Less than 10% of participants will be expected to experience these outcomes by 6 months. The focus of this analysis is to document any trends to inform the expected event rate for future studies.

Health-related quality of life scores will be determined by the RAND version of the 36-Item Short Form Health Survey (SF-36) administered pre-randomization and at 3-months and 6-months post-randomization. The physical composite summary (PCS) score of the SF-36 will be examined. The between-group difference in change in score, 6-month value minus pre-randomization value, will be reported with 95% CIs.

Health-related quality of life scores will be determined by the RAND version of the 36-Item Short Form Health Survey (SF-36) administered pre-randomization and at 3-months and 6-months post-randomization. The mental composite summary (MCS) score of the SF-36 will be examined. The between-group difference in change in score, 6-month value minus pre-randomization value, will be reported with 95% CIs.

To confirm our micro-particle curcumin was bioavailable, and to strengthen any relationship between micro-particle curcumin and any outcomes identified, serum levels of curcumin and its major metabolites will be measured in the first 30 participants 3 months after randomization (including patients taking micro-particle curcumin and those taking placebo). Serum curcumin and its major metabolites will be summarized in the first 30 participants randomized, by group. The between-group difference in average serum curcumin levels measured 3-months post-randomization will be reported with the 95% CI.

The investigators will conduct an exploratory subgroup analysis based on a higher or lower estimated risk of kidney failure, using the kidney failure risk equation. Participants with a 2-year risk of ESRD less than 10% will be classified as lower risk, and patients with a risk of 10% or more will be classified as higher risk.

Matthew Weir

Nephrologist, MD, FRCPC, MSc

Lawson Health Research Institute

The Kidney Foundation of Canada

Canadian Institutes of Health Research (CIHR)

The experimental group will receive the exclusion diet and nutraceutical therapy (DNT) and daily subcutaneously administered recombinant human growth hormone (rhGH) for the first 26 weeks. After 26 weeks this group will continue on the exclusion diet nutraceutical therapy for the remaining 26 weeks of the study.

The experimental group will receive the exclusion diet and nutraceutical therapy (DNT) and daily subcutaneously administered placebo injections for the first 26 weeks. After 26 weeks this group will continue on the exclusion diet and nutraceutical therapy for the remaining 26 weeks of the study.

Crohn's Disease

Humatrope will be administered daily to patients in a dose of .18-.20 mg/kg/week.

Growth Hormone

Nutraceutical Combination

Patients on the exclusion diet will adhere from consumption of all grain, corn, dairy, and carrageenan containing products.

Exclusion Diet

Placebo Growth Hormone

Columbia University Department of Clinical Genetics

Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease

Growth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical Trial

The proportion of patients in remission in each group will be assessed and compared to each other in order to demonstrate efficacy of treatment. Remission will be assessed by a change in the patients PCDAI score to below 10.

BMD of the hip and spine will be obtained by dual-emission x-ray absorptiometry (DXA) at the baseline visit and week 52.

Columbia University

Coltect contains natural compounds: curcumin, green tea and selenium which are approved as food supplements by the Ministry of Health in Israel. Curcumin and green tea are widely used in the food industry.

Ulcerative Colitis

Two tablets twice daily (BID) during the 2 months of the study. Each tablet contains 500mg Curcumin, 250mg Green tea and 100mcg Selenomethionine.

curcumin/ripuli

Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease

Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease

The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label

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