Efficacy and Safety of Modified ORS(Amr and Khulood ORS) in Diabetic Pilgrims During Hajj (AA-HAMS-ORS)

Efficacy and Safety of Modified Oral Rehydration Salts (ORS) in Diabetic Pilgrims With Heat Stress and Dehydration During the Hajj Mass Gathering: A Three-Arm, Active-Controlled, Randomized Clinical Trial

Heat stress and dehydration are significant risks for diabetic pilgrims during the Hajj, often leading to severe complications. Standard Oral Rehydration Salts (ORS) are effective for rehydration but may cause hyperglycemia in diabetic patients due to their glucose content. This study aims to evaluate the efficacy and safety of a modified ORS formula ( Amr and khulood ORS) , specifically designed for diabetic individuals, in maintaining hydration without adversely affecting blood glucose levels. The study will involve a randomized controlled trial comparing the modified ORS (Amr and khulood ORS) with standard ORS among diabetic pilgrims experiencing heat stress. Key outcomes include hydration status, electrolyte balance, and glycemic control.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; Heat Stress
• Intervention / Treatment: Other: Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS); Other: Standard Oral Rehydration Salts (ORS)

Detailed Description

Background: The Hajj pilgrimage involves strenuous physical activity in extreme heat, posing a high risk of dehydration and heat-related illnesses, particularly for diabetic patients. Standard ORS, while lifesaving, contains glucose that can exacerbate hyperglycemia.

Objective: To assess whether a modified ORS (Amr and khulood ORS) (with reduced or alternative carbohydrate sources) can safely and effectively rehydrate diabetic pilgrims.

Methods: This is a prospective, randomized, double-blind controlled trial. Participants will be diabetic pilgrims presenting with signs of mild to moderate dehydration. They will be randomized to receive either the modified ORS ( Amr and khulood ORS) or the WHO standard ORS.

Measurements: Blood glucose levels, serum electrolytes, urine specific gravity, and clinical signs of rehydration will be monitored at baseline and at regular intervals (2, 4, and 6 hours) post-intervention.

Safety: Adverse events, including severe hyperglycemia or hypoglycemia, will be recorded.

Significance: If proven effective, the modified ORS ( Amr and khulood ORS) could become a standard of care for diabetic individuals in heat-intensive environments, improving safety and health outcomes during Hajj.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: amr Central Research Office; Phone Number: +966597310032; Email: amrka@moh.gov.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Ministry of health
    • Contact: Principal Investigator; Phone Number: +966597310032; Email: drmedahmed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diabetic pilgrims attending Hajj.
• Age between 18 and 80 years.
• Willingness to participate and provide informed consent.
• Diagnosis of Type 1 or Type 2 Diabetes Mellitus.

Exclusion Criteria:

• Patients with severe renal failure.
• Patients with acute cardiovascular events.
• Patients unable to take oral fluids.
• Pregnancy or breastfeeding.
• Participation in another clinical trial within the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified ORS Group; Participants in this group will receive the modified Oral Rehydration Salts ( Amr and khulood ORS) specifically designed for diabetic patients during the Hajj season to prevent dehydration and maintain electrolyte balance.	Other: Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS); Modified ORS formula ( Amr and khulood ORS) with adjusted electrolyte and carbohydrate content suitable for diabetic patients to prevent heat-related dehydration.
Active Comparator: Standard ORS Group; Participants in this group will receive the standard World Health Organization (WHO) Oral Rehydration Salts (ORS) formula.	Other: Standard Oral Rehydration Salts (ORS); Standard World Health Organization (WHO) ORS formula used as an active comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum sodium levels from baseline to post-treatment	Assessment of electrolyte balance by measuring the change in serum sodium levels (mmol/L) after the administration of ORS.	Baseline and 24 hours post-treatment

Collaborators and Investigators

• Sponsor: Amr kamel khalil Ahmed
• Collaborators: Ministry of Health, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Wounds and Injuries; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Heat Stress Disorders
• Other Study ID Numbers: Hajj-Diabetes-amr&khulood-V1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No