- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734288
LIFEHOUSE: Description of the Tent Bucket -Immune Support (LIFEHOUSE)
LIFEHOUSE: a Lifestyle Intervention and Functional Evaluation- a Health OUtcome SurvEy; Description of the Tent Bucket -Immune Support
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Gig Harbor, Washington, United States, 98332
- Personalized Lifestyle Medicine Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Immune response
This is a single-arm study.
All subjects will be treated equally and will receive the same type and amount of nutritional supplements.
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The subjects will receive monthly (for either 3 or 6 months):
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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12 weeks (Phase 1) or up to 6 months (Phase 2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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).
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12 weeks (Phase 1) or up to 6 months (Phase 2)
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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)
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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).
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12 weeks (Phase 1) or up to 6 months (Phase 2)
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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)
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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.
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12 weeks (Phase 1) or up to 6 months (Phase 2)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Josesph J Lamb, MD, Medical Director
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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