Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aquamin® as an Adjuvant Intervention for Ulcerative Colitis In Remission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03869905
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
James Varani, University of Michigan

Brief Summary:
The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will extend remission in patients with stable Ulcerative Colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Aquamin® Drug: Placebo first then Aquamin® Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This pilot study includes individuals with ulcerative colitis in stable remission, and is a randomized, double-blind, placebo-controlled trial with two parallel treatment groups for the first 90 days. Subjects on placebo will be crossed over to Aquamin® after the halfway visit at day 90. Subjects on Aquamin® will continue their treatment till the end.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Ulcerative Colitis in Remission
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aquamin®
To be taken for 180 days
Drug: Aquamin®
4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)
Other Name: Nutritional

Placebo Comparator: Placebo first then Aquamin®
Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)
Drug: Aquamin®
4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)
Other Name: Nutritional

Drug: Placebo first then Aquamin®
4 capsules per day; 2 to be taken in the morning and 2 in the evening
Other Name: Maltodextrin




Primary Outcome Measures :
  1. Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score [ Time Frame: Up to day 180 ]
    This is a self-administered questionnaire. There are 32 quality of life questions related to bowel function. Each response corresponds to a letter 'a' through 'g'. Whereas 'a' indicates high frequency and 'g' indicates minimal frequency. The total IBDQ score ranges between 32 and 224, with higher scores indicating better quality of life.

  2. Change in clinical assessment /gastroenterologist's endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring [ Time Frame: Up to day 180 ]
    UCDAI/Mayo Scoring consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.

  3. Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Up to day 180 ]
    Interleukin 8 levels are measured in picograms per milliliter (pg/mL)

  4. Change in serum C-reactive protein (CRP) levels as measured in a blood sample. [ Time Frame: Up to day 180 ]
    Serum C-reactive protein ([CRP levels)] will be reported in milligram per deciliter (mg/dL)

  5. Change in fecal calprotectin levels measured in a stool sample [ Time Frame: Up to day 180 ]
    Fecal calprotectin will be reported in microgram per gram (µg/g)


Secondary Outcome Measures :
  1. Changes in serum liver function tests [ Time Frame: Up to day 180 ]
    Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with a maintenance therapy (except steroids and antibiotics for 3 months)
  • A negative pregnancy test

Exclusion Criteria:

  • No history or diagnosis of any of the following conditions: Chron's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin.
  • Ingested certain medications (Calcium, Vitamin D, fiber supplements and Non-steroidal anti-inflammatory drugs - NSAIDs) within 30 days of study start.

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): NCT03869905


Contacts
Layout table for location contacts
Contact: Muhammad Nadeem Aslam 734-936-1897 mnaslam@umich.edu

Locations
Layout table for location information
United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Sub-Investigator: Muhammad N Aslam         
Sponsors and Collaborators
James Varani
Investigators
Layout table for investigator information
Principal Investigator: James Varani University of Michigan

Layout table for additonal information
Responsible Party: James Varani, Professor of Pathology, University of Michigan
ClinicalTrials.gov Identifier: NCT03869905     History of Changes
Other Study ID Numbers: HUM00156676
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Varani, University of Michigan:
Remission
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases