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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchial Asthma; Asthma Chronic
• Intervention / Treatment: Dietary supplement: Chromium picolinate

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hieba Gamal Gamal Ezz El Regal, PhD; Phone Number: +2 01002041611; Email: hiebagamal24@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Profile	Change in fasting total, HDL, LDL Cholesterol in addition to the triglycerides	From baseline to 12 weeks
Anthropometric Measurements	Change in Body Mass Index (BMI) Unit of Measure: kg/m²	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.	Monthly from baseline to 3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): August 20, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 11, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Weight loss; chromium
• Additional Relevant MeSH Terms: Body Weight; Immune System Diseases; Respiratory Tract Diseases; Body Weight Changes; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss; Asthma; picolinic acid
• Other Study ID Numbers: FMASU R62/2026 (Registry Identifier: Ain Shams Faculty of Medicine Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No