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

NCT07618702 | Not Yet Recruiting

• 1 other identifier: Hajj-Diabetes-amr&khulood-V1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Heat Stress

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Modified ORS Group

EXPERIMENTAL

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)

Standard ORS Group

ACTIVE COMPARATOR

Participants in this group will receive the standard World Health Organization (WHO) Oral Rehydration Salts (ORS) formula.

Other: Standard Oral Rehydration Salts (ORS)

Interventions

Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS) OTHER

Modified ORS formula ( Amr and khulood ORS) with adjusted electrolyte and carbohydrate content suitable for diabetic patients to prevent heat-related dehydration.

Modified ORS Group

Standard Oral Rehydration Salts (ORS) OTHER

Standard World Health Organization (WHO) ORS formula used as an active comparator.

Standard ORS Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amr kamel khalil Ahmed: lead
• Ministry of Health, Saudi Arabia: collaborator

Study Sites (1)

Ministry of health

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Heat Stress Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Wounds and Injuries

Central Study Contacts

amr Central Research Office

CONTACT

+966597310032; amrka@moh.gov.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

SA (1)