Asthma ChronicECWACNCT07703358
Effect of Chromium Weight Reduction on Adult Asthma Control
A study testing Chromium picolinate in people with Asthma Chronic and Bronchial Asthma, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma Chronic, Bronchial Asthma
- What is being tested?
- Chromium picolinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 20 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Asthma Chronic, Bronchial Asthma
- Being tested
- Chromium picolinate
- Keywords
- chromium, Asthma, Weight loss
- Medical subject headings
- Asthma, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromium picolinateDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | All 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 | Experimental | 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. Receives: Dietary Supplement: Chromium picolinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma control
Change in Asthma Control Test (ACT) Score (points; range 5-25)
Measured: from baseline to 12 weeks
Spirometry
Forced Expiratory Volume in 1 second (FEV₁) - L or % predicted
Measured: from baseline to 12 weeks
Frequency of rescue medication use
Frequency of Asthma Inhalers used
Measured: from baseline to 12 weeks
Asthma exacerbation frequency
Asthma exacerbation frequency
Measured: from baseline to 12 weeks
Secondary outcomes (3)
Lipid Profile
Change in fasting total, HDL, LDL Cholesterol in addition to the triglycerides
Measured: From baseline to 12 weeks
Anthropometric Measurements
Change in Body Mass Index (BMI) Unit of Measure: kg/m²
Measured: From baseline to 12 weeks
Incidence of Treatment-Emergent Adverse Events
The outcome measure will assess the frequency of adverse effects occurring during the study period.
Measured: Monthly from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChronicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Chromium Picolinate
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Amani Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703358
- Sponsor's protocol ID
- FMASU R62/2026
- Other IDs
- FMASU R62/2026
- Acronym
- ECWAC
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chromium Weight Reduction on Adult Asthma Control
- ClinicalTrials.gov ID
- NCT07703358
- Acronym / sponsor ID
- ECWAC / FMASU R62/2026
- Conditions
- Asthma Chronic, Bronchial Asthma
- Keywords
- chromium, Asthma, Weight loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Chromium Picolinate
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –All 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 | Experimental | Dietary Supplement: Chromium picolinateTwo tablets collectively containing 400 mcg of Chromium picolinate which is equivalent to 49.4 mcg of elemental chromium. Taken once daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromium picolinateTwo tablets collectively containing 400 mcg of Chromium picolinate which is equivalent to 49.4 mcg of elemental chromium. Taken once daily for 12 weeks. | Dietary supplement | Chromium Picolinate |
Primary outcome
Change in asthma control
Time frame: from baseline to 12 weeks
Change in Asthma Control Test (ACT) Score (points; range 5-25)
Spirometry
Time frame: from baseline to 12 weeks
Forced Expiratory Volume in 1 second (FEV₁) - L or % predicted
Frequency of rescue medication use
Time frame: from baseline to 12 weeks
Frequency of Asthma Inhalers used
Asthma exacerbation frequency
Time frame: from baseline to 12 weeks
Asthma exacerbation frequency
3 secondary outcomes
Lipid Profile
Time frame: From baseline to 12 weeks
Anthropometric Measurements
Time frame: From baseline to 12 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: Monthly from baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Chromium picolinate in people with Asthma Chronic and Bronchial Asthma, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hieba Gamal Gamal Ezz El Regal, PhD (01002041611 ext. +2, hiebagamal24@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in asthma control (time frame: from baseline to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.