Effect of Chromium Weight Reduction on Adult Asthma Control (ECWAC)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hieba Gamal Gamal Ezz El Regal, PhD
- Telefonnummer: +2 01002041611
- E-post: hiebagamal24@med.asu.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Standard of Care
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. |
|
|
Eksperimentell: Chromium Picolinate
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. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in asthma control
Tidsramme: from baseline to 12 weeks
|
Change in Asthma Control Test (ACT) Score (points; range 5-25)
|
from baseline to 12 weeks
|
|
Spirometry
Tidsramme: from baseline to 12 weeks
|
Forced Expiratory Volume in 1 second (FEV₁) - L or % predicted
|
from baseline to 12 weeks
|
|
Frequency of rescue medication use
Tidsramme: from baseline to 12 weeks
|
Frequency of Asthma Inhalers used
|
from baseline to 12 weeks
|
|
Asthma exacerbation frequency
Tidsramme: from baseline to 12 weeks
|
Asthma exacerbation frequency
|
from baseline to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lipid Profile
Tidsramme: From baseline to 12 weeks
|
Change in fasting total, HDL, LDL Cholesterol in addition to the triglycerides
|
From baseline to 12 weeks
|
|
Anthropometric Measurements
Tidsramme: From baseline to 12 weeks
|
Change in Body Mass Index (BMI) Unit of Measure: kg/m²
|
From baseline to 12 weeks
|
|
Incidence of Treatment-Emergent Adverse Events
Tidsramme: Monthly from baseline to 3 months
|
The outcome measure will assess the frequency of adverse effects occurring during the study period.
|
Monthly from baseline to 3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FMASU R62/2026 (Registeridentifikator: Ain Shams Faculty of Medicine Institutional Review Board)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
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