LIFEHOUSE: Description of the Tent Bucket -Immune Support

Metagenics

Status

Completed

Conditions

Immune Response

Treatments

Dietary Supplement: Vit.D3 5000 IU, Immune Active

Study type

Interventional

Funder types

Industry

Identifiers

NCT04734288

2020-002

Details and patient eligibility

About

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.

Full 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).

Enrollment

7 patients

Sex

All

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

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.