Electrolyte Drinks for Dehydration
(LIV-D2O Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Arizona State University
Must not be taking: Thyroid medication
Disqualifiers: Cardiovascular, Renal, Hepatic, others
Trial Summary
What is the purpose of this trial?It is well established that rehydration with a carbohydrate-electrolyte solution is more effective in comparison to plain water. This is primarily based on the sodium-glucose co transporter, based on which the world health organization has based its oral rehydration solution recommendations. Also, rehydration with a solution that includes sodium and glucose plasma osmolality should not drop as much as it happens during rehydration with water. As a result, we should have higher fluid intake due to higher thirst perception and lower urinary output due to higher levels of vasopressin.
The present study aims to examine the effectiveness of a electrolyte-glucose drink on rehydration following exercise-induced dehydration.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on thyroid medication.
Is it safe to use electrolyte drinks for dehydration?
Research shows that oral rehydration solutions (ORS), including those with glucose and electrolytes, are generally safe for treating dehydration in humans, including children with gastroenteritis. No adverse effects were reported in studies, but it's important to use the correct formulation for specific conditions, like cholera, to avoid complications such as low sodium levels.
12345How is the treatment Liquid IV Hydration Multiplier different from other treatments for dehydration?
Liquid IV Hydration Multiplier is unique because it offers a convenient oral rehydration solution (ORS) that can be used at home, combining electrolytes and glucose to effectively rehydrate the body. Unlike some traditional ORS formulations, it may provide a more balanced electrolyte composition suitable for both cholera and non-cholera dehydration, potentially reducing the risk of complications like hyponatremia (low sodium levels).
12467Eligibility Criteria
This trial is for adults aged 18-60 who exercise at least twice a week and have maintained a stable weight (less than 5 pounds change) over the last two months. It's not suitable for those with night shift work, on thyroid meds, past bariatric surgery, or with heart, kidney, liver diseases. Also excluded are those in another study or weighing over 110 pounds.Inclusion Criteria
Training at least 2 times per week
Stable weight for the last 2 months (fluctuation less than 5 pounds)
I am between 18 and 60 years old.
Exclusion Criteria
I have a heart condition.
Night shifting work
I have had weight loss surgery.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo rehydration with either a carbohydrate-electrolyte solution or water following exercise-induced dehydration
4 hours
1 visit (in-person)
Follow-up
Participants are monitored for rehydration effectiveness and physiological responses
4 hours
1 visit (in-person)
Participant Groups
The study tests how well different drinks rehydrate after exercise-induced dehydration: plain water versus Liquid IV Sugar Free and Liquid IV Hydration Multiplier—both containing electrolytes and glucose which may enhance fluid intake and reduce urine output.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Sugar electrolyte solutionExperimental Treatment1 Intervention
10 grams of carbohydrate, 1060 milligrams of sodium, and 760 milligrams of potassium per liter. Sugar free Liquid IV
Group II: Carbohydrate Electrolyte solutionExperimental Treatment1 Intervention
Drink with 22 grams of carbohydrate, 1020 milligrams of sodium, and 760 milligrams of potassium per liter. Hydration multiplier liquid IV
Group III: WaterPlacebo Group1 Intervention
Rehydration with low mineral content bottle water
Liquid IV Hydration Multiplier is already approved in European Union, United States, Australia, United Kingdom for the following indications:
🇪🇺 Approved in European Union as Oral Rehydration Solution (ORS) for:
- Dehydration due to diarrhea
- Dehydration due to vomiting
- Exercise-induced dehydration
🇺🇸 Approved in United States as Oral Rehydration Therapy (ORT) for:
- Mild to moderate dehydration
- Diarrhea
- Vomiting
- Exercise-induced dehydration
🇦🇺 Approved in Australia as Oral Rehydration Solution (ORS) for:
- Dehydration due to diarrhea
- Dehydration due to vomiting
🇬🇧 Approved in United Kingdom as Oral Rehydration Solution (ORS) for:
- Dehydration due to diarrhea
- Dehydration due to vomiting
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Interdisciplinary Science and Technology Building 8Phoenix, AZ
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Who Is Running the Clinical Trial?
Arizona State UniversityLead Sponsor
References
Oral rehydration therapy. [2019]Oral rehydration therapy (ORT) with glucose-electrolyte solutions has been considered to be one of the greatest therapeutic advances of this century. ORT is effective in acute diarrheal disease of diverse etiology. The most widely used oral rehydration solution (ORS) worldwide is that recommended by the World Health Organisation (Na 90, K 20, glucose 111 and citrate 10 mmol/L). Attempts to improve the efficacy of ORS have been made by using complex substrates (rice and other cereals) in place of glucose, and by reducing osmolality by decreasing glucose and sodium concentrations in monomeric ORS. ORS may have wider applications in the management of patients with the short bowel syndrome and in post-surgical patients.
Efficacy of Glucose or Amino Acid-Based Commercial Beverages in Meeting Oral Rehydration Therapy Goals After Acute Hypertonic and Isotonic Dehydration. [2019]The efficacy of different commercial beverage compositions for meeting oral rehydration therapy (ORT) goals in the treatment of acute dehydration in healthy humans has not been systematically tested. The objective of the study was to compare fluid retention, plasma volume (PV), and interstitial fluid (ISF) volume restoration when using 1 popular glucose-based and 1 novel amino acid-based (AA) commercial ORT beverage following experimental hypertonic or isotonic dehydration.
Clinical experience with a hypotonic oral rehydration solution for treatment of pediatric gastroenteritis in the United Kingdom. [2016]Animal and human perfusion studies suggest that water absorption can be optimized by glucose-electrolyte solutions with low total osmolality. A new oral rehydration solution (ORS), reformulated Dioralyte (RD), containing 60 mmol/L of sodium and 90 mmol/L of glucose with an osmolality of 240 mosm/kg, was tested for safety and efficacy in children in the United Kingdom with acute gastroenteritis. In a double-blind, controlled trial, RD was compared with standard Dioralyte (SD), a widely used low-sodium, high-glucose solution containing 35 mmol/L of sodium and 200 mmol/L of glucose, with an osmolality of 310 mosm/kg. Infants and children aged 2 weeks to 3 years admitted with acute gastroenteritis of less than five days' duration and mild to moderate dehydration were randomized to receive either RD or SD. Clinical and laboratory assessments were made on admission and 12, 24, and 48 hours after treatment. Thirty-two children were enrolled in the study; 14 received RD and 18 SD. No adverse effects from either ORS were reported. Efficacy was evaluated in 24 patients, of whom eight received RD and 16 SD. Total ORS intake and intake in milliliters per kilogram were similar in both treatment groups. Mean fluid balance, mean percentage weight change, and median stool frequency did not differ between the groups at 12, 24, and 48 hours after onset of treatment. Three (12.5%) patients had greater than or equal to 0.05% reducing substances in the stool during treatment, and the incidence was similar in both groups.(ABSTRACT TRUNCATED AT 250 WORDS)
Issues and Controversies in the Evolution of Oral Rehydration Therapy (ORT). [2022]The original studies demonstrating the efficacy of oral glucose-electrolytes solutions in reducing or eliminating the need for intravenous therapy to correct dehydration caused by acute watery diarrheas (AWD) were focused chiefly on cholera patients. Later research adapted the oral therapy (ORT) methodology for treatment of non-cholera AWDs including for pediatric patients. These adaptations included the 2:1 regimen using 2 parts of the original WHO oral rehydration solution (ORS) formulation followed by 1 part additional plain water, and a "low sodium" packet formulation with similar average electrolyte and glucose concentrations when dissolved in the recommended volume of water. The programmatic desire for a single ORS packet formulation has led to controversy over use of the "low sodium" formulations to treat cholera patients. This is the subject of the current review, with the conclusion that use of the low-sodium ORS to treat cholera patients leads to negative sodium balance, leading to hyponatremia and, in severe cases, particularly in pediatric cholera, to seizures and other complications of sodium depletion. Therefore it is recommended that two separate ORS packet formulations be used, one for cholera therapy and the other for non-cholera pediatric AWD.
Post-exercise rehydration: Comparing the efficacy of three commercial oral rehydration solutions. [2023]This study compared the efficacy of three commercial oral rehydration solutions (ORS) for restoring fluid and electrolyte balance, after exercise-induced dehydration.
Role of oral rehydration therapy in controlling epidemic of cholera and watery diarrhoea. [2004]Oral rehydration therapy (ORT) is basically oral administration of liquid containing various electrolytes in specific proportions to prevent and treat dehydration. This treatment facilitates safe and optimal absorption of water and essential electrolytes such as sodium chloride, sodium bicarbonate and potassium chloride in dehydrated patients. Successful ORT was experienced in cholera patients in Kolkata and Dhaka which was followed by the development of oral rehydration salt (ORS). This procedure can be safely implemented at home. ORT reduced mortality rate both in cholera and non-cholera watery diarrhoea. The various health authorities must support preparedness before pre-positioning of adequate stocks of ORS packets for emergency situations. Health workers should have been the knowledge to prepare ORS solutions.
Simplified treatment strategies to fluid therapy in diarrhea. [2018]Dehydration resulting from diarrhea remains an important cause of morbidity and mortality among infants and children worldwide. Although it is well established that rapid and generous intravenous restoration of extracellular fluid, followed by oral rehydration therapy (ORT) should be used in children with severe dehydration, physicians continue to be reluctant to use such therapy. Applying the principle of body fluid physiology to the current treatment of dehydration, we developed a simple and yet effective treatment strategy to fluid therapy for children with diarrheal dehydration using commercially manufactured solutions. Children with mild-to-moderate dehydration are best treated with ORT using commercially available oral solutions containing 45-75 mEq/l of Na(+). Children who have clinical evidence of severe dehydration should receive intravenous fluids, 60-100 ml/kg of 0.9% saline in the first 2-4 h to restore circulation. Oliguric patients with severe acidosis should receive a physiological dose of bicarbonate to correct blood pH level to 7.25. Once circulation is restored, the ORT should be given in small quantities to replace losses of water and Na(+) over 6-8 h. Age-appropriate diet should be started as soon as tolerated. Those who cannot tolerate ORT should receive intravenous rehydration for the remainder of the deficit and maintenance. Addition of 20 mEq/l K(+) to rehydration solutions permits repair of cellular K(+ )deficits without risk of hyperkalemia. The amount of Na(+) given to replace maintenance and deficit fluids varies with the forms of dehydration. Isonatremic dehydration is best treated with 5% dextrose in 0.45% saline containing 20 mEq/l KCl over 24 h. Hyponatremic dehydration is best treated with 0.9% saline and 0.45% saline alternately in a 1:1 ratio in 5% dextrose containing 20 mEq/l KCl over 24 h. Hypernatremic dehydration is best treated with 5% dextrose in 0.2% saline containing 20 mEq/l KCl over 2-3 days to avoid cerebral edema. Maintenance hydration is best treated with 5% dextrose in 0.2% saline containing 20 mEq/l KCl. Ideal commercial intravenous maintenance and deficit solutions have yet to appear.