Comparison of Different Oral Rehydration Solutions

NCT02142582 | Completed

• 1 other identifier: 13-008346
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Compliance is the biggest challenge in patients with Short Bowel Syndrome (SBS) on Home Parenteral Nutrition. These patients need to hydrate themselves to meet the excess fluid loss due to their anatomy. Oral Rehydration Solution (ORS) is prescribed to all these patients. The investigators believe that taste of the standard ORS is the biggest reason why these patients are not complaint. The new ORS in the market has been prepared with this in mind. The investigators want to study if this new ORS will improve the compliance in this patient cohort.

Conditions

Short Bowel Syndrome

Keywords

Home Parenteral Nutrition; Compliance; Short Bowel Syndrome; Oral Rehydration Solution

Outcome Measures

Primary Outcomes (1)

• Number of patients who will regularly take Oral Rehydration Solution (ORS) when the newly available ORS is compared to the World Health Organisation ORS.

  6 months

Secondary Outcomes (1)

• Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS

  Baseline to 6 months

Study Arms (2)

WHO ORS

ACTIVE COMPARATOR

Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.

Dietary Supplement: WHO ORS

Commercial ORS

ACTIVE COMPARATOR

Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.

Dietary Supplement: Commercial ORS

Interventions

WHO ORS DIETARY_SUPPLEMENT

Participants will be randomized into one of the two groups. They will be provided with one of the two ORS solutions. Then, they will be followed for 6 months.

Also known as: World Health Organization ORS

WHO ORS

Commercial ORS DIETARY_SUPPLEMENT

Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.

Also known as: Dripdrop

Commercial ORS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with short bowel syndrome treated by the HPN program.

You may not qualify if:

• Participants who have do not provide written consent.
• Participants who lack the ability to provide informed consent
• Participants who are not anticipated to be on HPN for at least 6 months (determined by PrincipaI Investigator).
• Pregnant women
• Participants with pre-existing congestive heart failure, acute/ chronic kidney failure. (determined by the PrincipaI Investigator)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome; Patient Compliance; Osteoarthritis

Interventions

World Health Organization oral rehydration solution

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ryan Hurt, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 4, 2016

Record last verified: 2016-05

Locations

US (1)