An interventional study of Vit.D3 5000 IU, Immune Active in Immune Response, sponsored by Metagenics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Metagenics, Inc. · Not applicable, Interventional, and Supportive care
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.
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).
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →Metagenics, Inc. is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a single-arm study. All subjects will be treated equally and will receive the same type and amount of nutritional supplements.
Dietary Supplement: Vit.D3 5000 IU, Immune Active
The 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.
Also known as: Test kits- Vit.D and hs-CRP blood measurements, Questionnaires
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.
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 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).
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.
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).
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.
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.
Time frame: 12 weeks (Phase 1) or up to 6 months (Phase 2)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Jul 2022, 18 months.
Of 47 industry-sponsored interventional studies with no phase under Inflammation, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 18 months is above that.
Counting every sponsor, half of 924 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Metagenics, Inc.