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Not yet recruiting NCT07618702

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

No phase Interventional Diabetes Mellitus Heat Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS), Standard Oral Rehydration Salts (ORS).
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Heat Stress. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

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.

Interventions

  • 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.
  • Other Standard Oral Rehydration Salts (ORS)
    Standard World Health Organization (WHO) ORS formula used as an active comparator.

Primary outcome measures

  • Change in serum sodium levels from baseline to post-treatment [Time frame: Baseline and 24 hours post-treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Saudi Arabia · 1 center
  • Ministry of health — Riyadh

Identifiers

NCT: NCT07618702 · Hajj-Diabetes-amr&khulood-V1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗