Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-08

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This pilot study includes individuals with mild ulcerative colitis / ulcerative colitis in 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 until the end.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Aquamin®

To be taken for 180 days

Group Type EXPERIMENTAL

Aquamin®

Intervention Type DRUG

4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)

Placebo first then Aquamin®

Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)

Group Type PLACEBO_COMPARATOR

Aquamin®

Intervention Type DRUG

4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)

Placebo first then Aquamin®

Intervention Type DRUG

4 capsules per day; 2 to be taken in the morning and 2 in the evening

Interventions

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Aquamin®

4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)

Intervention Type DRUG

Placebo first then Aquamin®

4 capsules per day; 2 to be taken in the morning and 2 in the evening

Intervention Type DRUG

Other Intervention Names

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Nutritional Maltodextrin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No history or diagnosis of any of the following conditions: Crohn'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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No