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Effect of Chromium Weight Reduction on Adult Asthma Control

ConditionsAsthma ChronicBronchial Asthma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this trial

This phase IV randomized controlled trial is designed to evaluate the effects of chromium picolinate supplementation in obese adults with stable asthma. A total of 60 participants will be recruited from Ain Shams University Hospitals and randomly assigned to receive either 400 mcg of chromium picolinate daily or a matching placebo for 12 weeks, in addition to standard asthma therapy.

The study aims to explore the interaction between metabolic dysfunction and asthma, as obesity-related asthma is often associated with systemic inflammation, insulin resistance, and dyslipidemia. These factors may contribute to poorer asthma control and impaired pulmonary function, and therefore represent potential targets for adjunctive therapeutic interventions such as chromium supplementation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-65 years

Confirmed asthma diagnosis according to GINA criteria (7)

Asthma stable for at least 4 weeks (no acute exacerbation)

BMI of 30 kg/m² (obese category)

Disqualifiers

- Recent asthma exacerbation (within the last 4 weeks)

Any change in asthma medications within 4 weeks

renal or hepatic disease

Use of lipid-lowering drugs or supplements in the past 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chromium picolinate

    Dietary supplement

    Two tablets collectively containing 400 mcg of Chromium picolinate which is equivalent to 49.4 mcg of elemental chromium. Taken once daily for 12 weeks.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard of CareNo intervention 0 interventions
Group B: Chromium PicolinateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in asthma control

Change in Asthma Control Test (ACT) Score (points; range 5-25)

Time frame
from baseline to 12 weeks
2

Spirometry

Forced Expiratory Volume in 1 second (FEV₁) - L or % predicted

Time frame
from baseline to 12 weeks
3

Frequency of rescue medication use

Frequency of Asthma Inhalers used

Time frame
from baseline to 12 weeks
4

Asthma exacerbation frequency

Asthma exacerbation frequency

Time frame
from baseline to 12 weeks

Secondary outcomes

1

Lipid Profile

Change in fasting total, HDL, LDL Cholesterol in addition to the triglycerides

Time frame
From baseline to 12 weeks
2

Anthropometric Measurements

Change in Body Mass Index (BMI) Unit of Measure: kg/m²

Time frame
From baseline to 12 weeks
3

Incidence of Treatment-Emergent Adverse Events

The outcome measure will assess the frequency of adverse effects occurring during the study period.

Time frame
Monthly from baseline to 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Ain Shams University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: