Immune ResponseLIFEHOUSENCT04734288
LIFEHOUSE: Description of the Tent Bucket -Immune Support
A study testing Vit.D3 5000 IU, Immune Active in people with Immune Response, run by Metagenics, Inc. at 1 site in United States.
Trial summary
This immune support program will be an extension to the existing LIFEHOUSE program. Essential employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered complimentary supplementation with commercially available nutritional supplements supportive of immune health for… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response
- What is being tested?
- Vit.D3 5000 IU, Immune Active
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Ages 18-69, inclusive
- Metagenics' employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA
- General good health
- Willing to give written informed consent to participate in the study
Who cannot join
- An allergy to any ingredient in Vit.D3 5000 and/or Immune Active
- A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic/rheumatological, or oncological/hematologic disease.
- Hyperparathyroidism
- Granulomatous disorders including as sarcoidosis, tuberculosis, leprosy, berylliosis, histoplasmosis, and coccidioidomycosis
- Chronic renal insufficiency
- Nephrolithiasis
Show all 18Show fewer
- Prior cancer diagnosis
- Known infection with human immunodeficiency virus (HIV), tuberculosis (TB), or Hepatitis B or C.
- Established psychiatric disease including moderate to severe depression, thought disorders and bipolar disorder
- Planned use of nutritional supplements (exclusive of multiple vitamin/mineral supplements and medical foods) containing in total more than 1,000 IU Vitamin D3 and/or 10 mg Zinc
- Use of pharmaceutical nitrates for any indication
- Use of drugs of abuse and recreational drugs/substances (such as but not limited to opioids, cocaine, phencyclidine (PCP), and methamphetamine)
- History of marijuana or cannabinoid abuse within 12 months prior to screening and for the duration of the study.
- History of alcohol abuse or a diagnosis of alcoholism within 12 months prior to screening and for the duration of the study.
- Pregnant or breastfeeding women
- Inability to comply with study and/or follow-up visits.
- Any concurrent condition (including clinically significant abnormalities in medical history, physical examination or laboratory evaluations) which, in the opinion of the Principal Investigator (PI), would preclude safe participation in this study or interfere with compliance.
- Any sound medical, psychiatric, and/or social reason which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Personalized Lifestyle Medicine Center
Gig Harbor, Washington, 98332
About this study
Official title: LIFEHOUSE: a Lifestyle Intervention and Functional Evaluation- a Health OUtcome SurvEy; Description of the Tent Bucket -Immune Support
This immune support program will be an extension to the existing LIFEHOUSE program. Essential employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered complimentary supplementation with commercially available nutritional supplements supportive of immune health for several months. The outcome will be measured via blood parameters and questionnaire responses.
Read the detailed description
This program, as a component of the LIFEHOUSE program, will consist of data collection during a period of supplementation with commercially available nutritional supplements supportive of immune health. Employees, in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered the opportunity to participate.
The nutritional and inflammatory status will be captured via fingerstick biomarkers. Participants will receive in-home testing kits including instructions regarding the applicable fingerstick blood collections. Fingerstick testing will include 25-Hydroxy Vitamin D3 (25-OH D3) and high sensitivity c-reactive protein (hs-CRP) measurements at baseline, 1, and 2 (phase 1), or at baseline 1,2, 3, and 6 months intervals (phase 2).
Participants will also be asked to complete applicable questionnaires (QNs) electronically monthly using standard software programs for questionnaire completion.
This will include the Medical Outcome Study (MOS) Short Form (SF) -36 (baseline and monthly) and Health Status QNs including questions on compliance, wellbeing, lifestyle (exercise, shifts worked, medications and supplements, and diet) (baseline and monthly).
- Conditions
- Immune Response
- Being tested
- Vit.D3 5000 IU, Immune Active
- Keywords
- Nutritional Supplements, Vitamin (Vit.) D3, hs-CRP, Inflammation, Employee wellness program
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit.D3 5000 IU, Immune ActiveDietary supplement
Also called Test kits- Vit.D and hs-CRP blood measurements, Questionnaires
The subjects will receive monthly (for either 3 or 6 months):
- Vit.D3 5000 and Immune Active. The first phase includes 3 months of treatment and the second phase includes 6 months of treatment.
- An in-home Vit.D/ hs-CRP test kit and asked to self-administer a blood collection via fingerstick and return the kits for analysis within a few days.
- Two online questionnaires each month and asked to fill them out within a few days. It will either be the Medical Outcomes Study (MOS) Short Form (SF)-36 and the Health Status Baseline or Health Status Follow-up Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Immune response | Experimental | This is a single-arm study. All subjects will be treated equally and will receive the same type and amount of nutritional supplements. Receives: Dietary Supplement: Vit.D3 5000 IU, Immune Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of health.
The primary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically a marker of nutritional status (25-hydroxy Vitamin D3 (25-OH D3)) and a marker of immune balance (high sensitivity c-reactive protein (hs-CRP) in a real-world setting.
Measured: 12 weeks (Phase 1) or up to 6 months (Phase 2)
Secondary outcomes (3)
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of quality of life.
The first secondary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically upon quality of life as measured by Rand Medical Outcome Study 36-Item Short Form Survey (MOS SF-36).
Measured: 12 weeks (Phase 1) or up to 6 months (Phase 2)
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of the absence of infections.
The second secondary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically experience-defined events (tally of well days during assessed periods and absence of laboratory-confirmed SARS-CoV-2 and Influenza infections).
Measured: 12 weeks (Phase 1) or up to 6 months (Phase 2)
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of weight and body composition.
The third secondary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically in weight and body composition.
Measured: 12 weeks (Phase 1) or up to 6 months (Phase 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start22 Jan 2021
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm cohort intervention study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metagenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MetaProteomics LLC
- Responsible party
- Sponsor
- Investigators
- Josesph J Lamb, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734288
- Sponsor's protocol ID
- 2020-002
- Acronym
- LIFEHOUSE
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFEHOUSE: a Lifestyle Intervention and Functional Evaluation- a Health OUtcome SurvEy; Description of the Tent Bucket -Immune Support
- ClinicalTrials.gov ID
- NCT04734288
- Acronym / sponsor ID
- LIFEHOUSE / 2020-002
- Conditions
- Immune Response
- Keywords
- Nutritional Supplements, Vitamin (Vit.) D3, hs-CRP, Inflammation, Employee wellness program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Metagenics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MetaProteomics LLC
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Feb 2021 (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 immune support program will be an extension to the existing LIFEHOUSE program. Essential employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered complimentary supplementation with commercially available nutritional supplements supportive of immune health for several months. The outcome will be measured via blood parameters and questionnaire responses.
Detailed description
This program, as a component of the LIFEHOUSE program, will consist of data collection during a period of supplementation with commercially available nutritional supplements supportive of immune health. Employees, in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will be offered the opportunity to participate.
The nutritional and inflammatory status will be captured via fingerstick biomarkers. Participants will receive in-home testing kits including instructions regarding the applicable fingerstick blood collections. Fingerstick testing will include 25-Hydroxy Vitamin D3 (25-OH D3) and high sensitivity c-reactive protein (hs-CRP) measurements at baseline, 1, and 2 (phase 1), or at baseline 1,2, 3, and 6 months intervals (phase 2).
Participants will also be asked to complete applicable questionnaires (QNs) electronically monthly using standard software programs for questionnaire completion.
This will include the Medical Outcome Study (MOS) Short Form (SF) -36 (baseline and monthly) and Health Status QNs including questions on compliance, wellbeing, lifestyle (exercise, shifts worked, medications and supplements, and diet) (baseline and monthly).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm cohort intervention study
| Arm | Type | Receives |
|---|---|---|
| Immune response | Experimental | Dietary Supplement: Vit.D3 5000 IU, Immune ActiveThis is a single-arm study. All subjects will be treated equally and will receive the same type and amount of nutritional supplements. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- Ages 18-69, inclusive
- Metagenics' employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA
- General good health
- Willing to give written informed consent to participate in the study
Key exclusion criteria (18 listed)
- An allergy to any ingredient in Vit.D3 5000 and/or Immune Active
- A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic/rheumatological, or oncological/hematologic disease.
- Hyperparathyroidism
- Granulomatous disorders including as sarcoidosis, tuberculosis, leprosy, berylliosis, histoplasmosis, and coccidioidomycosis
- Chronic renal insufficiency
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 |
|---|---|---|
| Vit.D3 5000 IU, Immune ActiveAlso: Test kits- Vit.D and hs-CRP blood measurements, QuestionnairesThe subjects will receive monthly (for either 3 or 6 months): 1. Vit.D3 5000 and Immune Active. The first phase includes 3 months of treatment and the second phase includes 6 months of treatment. 2. An in-home Vit.D/ hs-CRP test kit and asked to self-administer a blood collection via fingerstick and return the kits for analysis within a few days. 3. Two online questionnaires each month and asked to fill them out within a few days. It will either be the Medical Outcomes Study (MOS) Short Form (SF)-36 and the Health Status Baseline or Health Status Follow-up Questionnaire. | Dietary supplement | Immune response |
Primary outcome
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of health.
Time frame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
The primary objective is to demonstrate the benefit of specific nutritional supplements, Vit.D3 5000 and Immune Active, as measured by demonstrable improvements in health, specifically a marker of nutritional status (25-hydroxy Vitamin D3 (25-OH D3)) and a marker of immune balance (high sensitivity c-reactive protein (hs-CRP) in a real-world setting.
3 secondary outcomes
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of quality of life.
Time frame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of the absence of infections.
Time frame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of weight and body composition.
Time frame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Josesph J Lamb, MD principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vit.D3 5000 IU, Immune Active in people with Immune Response, run by Metagenics, Inc. at 1 site in United States.
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 5 inclusion and 18 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: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The benefit of nutritional supplements (Vit.D3 5000, Immune Active) on the improvement of health. (time frame: 12 weeks (Phase 1) or up to 6 months (Phase 2)). 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 30 Oct 2023.