A Study Evaluating Quality of Life Parameters Following Use of Emergen-C

NCT06654089 | Completed Phase 4 Results

• 1 other identifier: 300217
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Supplements

Outcome Measures

Primary Outcomes (5)

• Adjusted Mean Change From Baseline in Multidimensional Fatigue Inventory (MFI) General Fatigue Domain Score at Week 12

  The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. General fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  Baseline and Week 12

• Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Week 12

  The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Physical fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reverse scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  Baseline and Week 12

• Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Week 12

  The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced activity domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.

  Baseline and Week 12

• Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Week 12

  The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Reduced motivation domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue symptoms. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in symptoms.

  Baseline and Week 12

• Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Week 12

  The MFI was a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Mental fatigue domain had 4 items. Participants answered how they felt about each item, on a scale of 1 (yes, that is true) to 5 (no, that is not true). Positively phrased items were reversely scored and negatively phrased items were scored at face value. The total domain score was calculated by summation of the scores of individual items and was ranged from 4 to 20 where lower scores indicated lower level of fatigue. Change from Baseline was calculated by subtracting the Baseline score from score at Week 12. A negative change from Baseline indicated improvement in fatigue.

  Baseline and Week 12

Secondary Outcomes (28)

• Adjusted Mean Change From Baseline in MFI General Fatigue Domain Score at Weeks 4 and 8

  Baseline, Week 4 and Week 8

• Adjusted Mean Change From Baseline in MFI Physical Fatigue Domain Score at Weeks 4 and 8

  Baseline, Week 4 and Week 8

• Adjusted Mean Change From Baseline in MFI Reduced Activity Domain Score at Weeks 4 and 8

  Baseline, Week 4 and Week 8

• Adjusted Mean Change From Baseline in MFI Reduced Motivation Domain Score at Weeks 4 and 8

  Baseline, Week 4 and Week 8

• Adjusted Mean Change From Baseline in MFI Mental Fatigue Domain Score at Weeks 4 and 8

  Baseline, Week 4 and Week 8

Study Arms (2)

Emergen-C Core Super Orange Powder (Test Product)

EXPERIMENTAL

Participants will be instructed to take the study product as per label instructions. Participants will consume one sachet of Emergen-C Core Super Orange Powder stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.

Dietary Supplement: Emergen-C Core Super Orange Powder

Placebo (Reference Product)

PLACEBO COMPARATOR

Participants will be instructed to take the study product as per label instructions. Participants will consume one sachet of placebo stirred in 4-6 ounces of water, orally, once daily for up to 12 weeks.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

A study product identical to the test product without active ingredients.

Placebo (Reference Product)

Emergen-C Core Super Orange Powder DIETARY_SUPPLEMENT

A dietary supplement powder containing vitamin C, zinc, vitamin B6, vitamin B12, folate, and manganese.

Emergen-C Core Super Orange Powder (Test Product)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Lindus Health Limited

New York, New York, 10017, United States

Location

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932959500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: October 30, 2024
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

US (1)