Effect of Chromium Weight Reduction on Adult Asthma Control

Study Design and Setting This study is a phase IV randomized controlled clinical trial (RCT) involving 60 adult patients diagnosed with asthma. Participants will be recruited from the outpatient clinic and pulmonary function unit of the Chest Department at Ain Shams University Hospitals.

Study Type: Phase IV randomized controlled clinical trial (RCT) Study Setting: Outpatient clinic and pulmonary function unit, Chest Department, Ain Shams University Hospitals Study Population: Adult patients with asthma, obesity, and diabetes mellitus

Sampling and Randomization Participants will be randomly assigned to study groups using computer-generated randomization sequences. Allocation concealment will be ensured through the use of sealed, opaque envelopes.

Ethical Considerations

The study protocol will be explained clearly to all eligible participants prior to enrollment.

The study will commence only after obtaining approval from the Ethical Committee of the Faculty of Medicine, Ain Shams University.

Written informed consent will be obtained from all participants prior to inclusion.

Participant safety will be prioritized, and all efforts will be made to minimize potential risks.

Confidentiality and anonymity of participant data will be strictly maintained. All participants will have an equal chance of being assigned to either study group.

No deceptive practices will be used during the study. Participants will have the right to withdraw from the study at any time without any consequences.

Study Procedures

All eligible participants will undergo the following assessments:

Demographic Data Collection: Age, sex, smoking status, and body mass index (BMI) Clinical Assessment: Detailed medical history including environmental exposures, potential risk factors, comorbidities, and duration of disease

Concomitant Care All participants will continue receiving standard asthma therapy throughout the study period.

Participants will be instructed to maintain a consistent intake of chromium-rich foods during the study to avoid dietary confounding.

Inclusion criteria

• 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)
• Stable inhaled corticosteroid + LABA regimen in the last 4 weeks
• The patient is compliant on his asthma medication
• Willing and able to provide informed consent
• willing to continue in the study, follow investigator instructions

Exclusion criteria

• - 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
• Use of Vitamin C, prostaglandin inhibitors, such as aspirin, oxalate, and antacids
• Current pregnancy or lactation
• Known allergy to chromium or adverse reaction to supplementation
• Participation in another interventional study in the past month
• History of heavy metal toxicity or chromium sensitivity
• Being on any weight control diet
• Being on a supplement containing chromium