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NCT Number: NCT07618702

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heat Stress Heat Stress Disorders Metabolic Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard Oral Rehydration Salts (ORS)

Other

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

Primary outcomes

  1. Change in serum sodium levels from baseline to post-treatment

    Time frame: Baseline and 24 hours post-treatment

    Assessment of electrolyte balance by measuring the change in serum sodium levels (mmol/L) after the administration of ORS.

Study contacts

Contact information is provided by the study sponsor or research team.

amr Central Research Office

CONTACT

[email protected]

+966597310032

Sponsors and collaborators

Lead sponsor

Amr kamel khalil Ahmed

Other Gov

Collaborators

  • Ministry of Health, Saudi Arabia

Registry information

Official study title

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

Acronym: AA-HAMS-ORS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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