Clinical trial NCT06654089: A Study Evaluating Quality of Life Parameters Following Use of Emergen-C
Official title: A Real-World Evidence Study Evaluating Quality of Life Parameters Following Use of Emergen-C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dietary Supplements
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine how Emergen-C use can improve quality of life (QoL) in a real-world setting to help consumers and healthcare professionals understand the benefits of taking Emergen-C on a routine or daily basis.

Detailed description: This will be a randomized, double-blinded, placebo-controlled clinical trial to evaluate the over-time effects of 12-weeks Emergen-C supplementation on QoL parameters in a real-world setting. This study will be entirely decentralized, and participants will not be required to physically attend any on-site visits. All study data will be collected remotely through a study platform using the participant's personal mobile device, tablet or computer. Sufficient participants will be screened to enroll approximately 300 eligible participants (approximately 150 participants per group) and approximately 240 participants are expected to complete the study (approximately 120 participants per group).

Eligibility criteria: Inclusion Criteria:

* Participant's provision of a signed and dated electronic informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
* Healthy adults, 18-64 years of age at the time of electronic consent (does not exclude any ethnicities, races, or gender identities).
* Participant is seeking to improve their energy/less fatigue levels.
* Participants whose baseline score is greater than or equal to (\>=) 10 on the dimension of general fatigue of the MFI and a score \>=3 for at least ten of the 20 questions of the MFI.
* Participants who are willing and able to comply with all study related activities as shown in the Schedule of Activities.
* Participants who reside in the United States (except for Hawaii and Alaska).
* Participants who own a mobile device, tablet or computer with access to stable internet connection and are willing to use their device to complete study surveys and assessments.

Exclusion Criteria:

* Participants who are either directly involved in the conduct of the study or a member of their immediate family; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
* Participants who have participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
* Participants who are pregnant, lactating, or plan to be pregnant or lactating during the course of the study (self-report).
* Participants with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
* Participants who are hypertensive or salt-sensitive should be excluded from this study.
* Participants who report being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day).
* Participants who are unable to read and understand English.
* Participants who report current and/or recent (up to 3 months ago) major illnesses and/ or major surgery.
* Participants who report a planned surgery during the study duration.
* Participants who report a diagnosis of heart failure, heart rhythm disturbances, severe liver disease, severe mental health diagnosis, or severe renal failure.
* Participants who report taking medications (in the previous 21 days) that have well established moderate or severe interaction with any of the study product ingredients: Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 milligrams (mg) per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, Monoamine Oxidase Inhibitors (MAOIs), or thyroid products.
* Participants who are currently taking a multivitamin or have taken a multivitamin in the past 30 days and are not willing to stop taking a multivitamin for the duration of the trial.
* Participants who are currently taking other Vitamin C or B supplements or have taken Vitamin C or B supplements in the past 30 days and are not willing to stop taking other Vitamin C or B supplements for the duration of the trial.
* Participants who are currently consuming energy drinks or energy shots or have consumed an energy drink or energy shot in the past 30 days and are not willing to stop consuming energy drinks and energy shots for the duration of the trial.
* A participant who has previously been enrolled in this study.
* A participant who, in the opinion of the investigator or delegate, should not participate in the study.

Primary outcomes:
measure: Change from Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain (Items 1,5,12,16) Score at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in MFI Physical Fatigue Domain (Items 2,8,14,20) Score at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in MFI Reduced Activity Domain (Items 3,6,10,17) Score at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in MFI Reduced Motivation Domain (Items 4,9,15,18) Score at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in MFI Mental Fatigue Domain (Items 7,11,13,19) Score at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from Baseline in MFI General Fatigue Domain (Items 1,5,12,16) Score at Weeks 4 and 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change from Baseline in MFI Physical Fatigue Domain (Items 2,8,14,20) Score at Weeks 4 and 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change from Baseline in MFI Reduced Activity Domain (Items 3,6,10,17) Score at Weeks 4 and 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change from Baseline in MFI Reduced Motivation Domain (Items 4,9,15,18) Score at Weeks 4 and 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change from Baseline in MFI Mental Fatigue Domain (Items 7,11,13,19) Score at Weeks 4 and 8
timeFrame: Baseline, Week 4 and Week 8
measure: Change from Baseline in Individual Items (Items 1 to 20) Score in the MFI at Weeks 4, 8 and 12
timeFrame: Baseline, Weeks 4, 8 and 12
measure: Change from Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Family Support
timeFrame: Baseline, Weeks 4, 8 and 12
measure: Change from Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Resilience
timeFrame: Baseline, Weeks 4, 8 and 12
measure: Change from Baseline in Additional QoL Parameter at Weeks 4, 8 and 12: Ability to Relax and Unwind
timeFrame: Baseline, Weeks 4, 8 and 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Lindus Health Limited
state: New York
Study officials:
References: