Effect of Chromium Weight Reduction on Adult Asthma Control
ECWAC
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedStudy Start
First participant enrolled
August 20, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2027
Study Completion
Last participant's last visit for all outcomes
August 20, 2027
July 14, 2026
July 1, 2026
1 year
April 8, 2026
July 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in asthma control
Change in Asthma Control Test (ACT) Score (points; range 5-25)
from baseline to 12 weeks
Spirometry
Forced Expiratory Volume in 1 second (FEV₁) - L or % predicted
from baseline to 12 weeks
Frequency of rescue medication use
Frequency of Asthma Inhalers used
from baseline to 12 weeks
Asthma exacerbation frequency
Asthma exacerbation frequency
from baseline to 12 weeks
Secondary Outcomes (3)
Lipid Profile
From baseline to 12 weeks
Anthropometric Measurements
From baseline to 12 weeks
Incidence of Treatment-Emergent Adverse Events
Monthly from baseline to 3 months
Study Arms (2)
Standard of Care
NO INTERVENTIONAll participants continue standard asthma therapy and management \- Study participants will be instructed to keep their dietary consumption of chromium rich foods constant all over the study period.
Chromium Picolinate
EXPERIMENTALTwo tablets collectively containing 400 mcg of Chromium picolinate which is equivalent to 49.4 mcg of elemental chromium. Taken once daily for 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Ain Shams Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Clinical Pharmacy
Study Record Dates
First Submitted
April 8, 2026
First Posted
July 14, 2026
Study Start (Estimated)
August 20, 2026
Primary Completion (Estimated)
August 20, 2027
Study Completion (Estimated)
August 20, 2027
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- De-identified individual participant data will be made available beginning 6 months after publication of the primary study results and will be available indefinitely.
- Access Criteria
- Data will be available upon reasonable request to the principal investigator. Requests will be reviewed for scientific merit and compliance with applicable ethical and regulatory requirements. Data-sharing agreements may be required before access is granted.
De-identified individual participant data underlying the results reported in publications arising from this study, including demographic, clinical, and outcome data, will be made available.