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Trial record 29 of 79 for:    Supplement | Turmeric

Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis.

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ClinicalTrials.gov Identifier: NCT03061591
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:
A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse Polyposis (FAP). Fourty Patients will be randomly assigned in a 1:1 ratio to recieve treatment with 8 capsuls (2*4 capsuls/day) of wholistic Turmeric capsules (Pukka herbs) or placebo for six months.

Condition or disease Intervention/treatment Phase
Familial Adenomatous Polyposis FAP FAP Gene Mutation Dietary Supplement: Wholistic Turmeric capsules Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 6 months of Curcumin vs. placebo treatment outcomes will be compared.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo and curcumin capsules are identical in appearance, and will be marked as "A" or "B". Study participants and staff will be blinded to the capsule content. A locked file containing the description will remain in a locked file on the study coordinators computer.
Primary Purpose: Treatment
Official Title: Efficacy of Wholistic Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis A Randomized, Double Blinded, Placebo Controlled Study
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Active Comparator: Wholistic Turmeric capsules

Oral capsules of wholistic Turmeric capsules (Pukka herbs) (each capsule 100 mg curcumin) divided twice daily, or an identical placebo in 2 divided doses daily all taken before meals.

Pukka's Wholistic Turmeric

Dietary Supplement: Wholistic Turmeric capsules
Oral capsules of wholistic Turmeric capsules (Pukka herbs) curcumin (each capsule 0.5100 m gr curcumin) for a total of 4 gr/d divided twice daily.

Placebo Comparator: Placebo
Identical placebo capsules
Other: Placebo
Placebo capsules




Primary Outcome Measures :
  1. Number of polyps [ Time Frame: 6 months ]
  2. Size of polyps [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Histological apoptosis assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression). [ Time Frame: 6 months ]
  2. Histological proliferation assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression). [ Time Frame: 6 months ]
  3. Colonic microbiome composition, after curcumin therapy. [ Time Frame: 6 months ]
  4. Duodenal adenoma number. [ Time Frame: 6 months ]
  5. Duodenal adenoma size. [ Time Frame: 6 months ]
  6. Curcumin and curcuminoid levels in blood. [ Time Frame: 6 months ]
  7. Curcumin and curcuminoid levels in urine. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. An established clinical diagnosis of Familial Polyposis based on accepted clinical/ endoscopic and an identified APC or MUTYH mutation
  2. Age 18-70 years.
  3. Willing and able to give written consent.
  4. At least 5 polyps, 2mm or lrager, with at least one larger then 4mm but not more then 20mm.
  5. Colonic polyp burden that can be estimated by either counting or photographing(photo or video).

Exclusion criteria:

  1. Pregnant or nursing women.
  2. Stable does of any COX inhibitor drugs for more than 3 months prior to study entry,.
  3. Concomitant severe or uncontrolled cardiovascular, hepatic, renal or metabolic disease.
  4. Known allergy to curcumin.
  5. Anticipated surgery within 6 months
  6. Diagnosed polyps of high grade dysplasia or of adenocarcinomas in the GI on screening colonoscopy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061591


Contacts
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Contact: Naomi Fliss, MSc 97236974458 naomifl@tlvmc.gov.il
Contact: Sivan Kaspi, RD 97236974458 sivanah@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Revital Kariv, MD Tel Aviv SMC

Publications:
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Responsible Party: michal roll, Head of Research and Development department, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03061591     History of Changes
Other Study ID Numbers: TASMC-15-RK-0601-CTIL
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
Turmeric
Curcumin
colorectal polyps
colorectal neoplasia
mutyh mutation
apc mutation
Additional relevant MeSH terms:
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Turmeric extract
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Curcumin
Anti-Inflammatory Agents, Non-Steroidal