Zinc Supplements for Immune Support on Navajo Nation

Overseen By Debra MacKenzie, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Must be taking: Zinc supplements

Must not be taking: Diabetes medications

Disqualifiers: Pregnancy, Diabetes, Zinc allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether zinc supplements (specifically Zinc Picolinate 15 mg) can reduce signs of metal toxicity in individuals living in certain Navajo Nation communities. Participants will take a daily zinc supplement for six months, and researchers will assess their health markers before and after the trial. This study is open to residents of Blue Gap-Tachee, Arizona, or Red Water Pond Road Community, New Mexico, who are willing to provide blood and urine samples and attend scheduled visits. As an unphased trial, it offers participants the chance to contribute to important research that could enhance community health.

Will I have to stop taking my current medications?

The trial requires participants to stop taking zinc supplements or multivitamins if they are currently using them. Other medications are not specifically mentioned, so it's unclear if you need to stop taking them.

What prior data suggests that zinc picolinate is safe for human use?

Research shows that taking zinc orally is generally safe in amounts up to 40 mg per day. This study uses a zinc supplement called zinc picolinate at a dose of 15 mg daily, well within the safe limit. Zinc helps the immune system and aids in wound healing.

Some individuals might experience mild side effects, such as an upset stomach or a metallic taste, but these are rare and usually not serious. Overall, taking zinc at this dose is considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for immune support, which often rely on a variety of vitamins and herbal supplements, zinc picolinate offers a targeted approach by using a specific form of zinc that is easily absorbed by the body. This unique formulation is believed to enhance immune function more effectively than general multivitamins. Researchers are excited about zinc picolinate because it provides a straightforward daily supplementation that could potentially improve immune resilience, especially in populations like the Navajo Nation that may benefit from accessible and effective immune support options.

What evidence suggests that zinc supplementation might be effective for mitigating metal toxicity?

Research shows that zinc is important for a healthy immune system. Zinc controls signals in cells that support both the body's first defense (innate immunity) and its more specialized second defense (adaptive immunity). Studies have found that zinc supplements can strengthen the immune system and reduce inflammation. Specifically, zinc supplements have been linked to higher blood zinc levels and may even increase CD4+ cell counts, which are important for fighting infections. In children, zinc intake has been associated with fewer respiratory infections. This trial will evaluate zinc picolinate to support immune health in people exposed to metal toxicity. Participants will receive this form of zinc. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men and women aged 21-64 living near Blue Gap-Tachee, AZ or Red Water Pond Road, NM who are willing to take daily zinc supplements and provide blood and urine samples. Excluded are those with copper homeostasis syndromes, current zinc supplement users unwilling to stop, diabetics, anyone allergic to zinc, or pregnant/nursing women.

Inclusion Criteria

I am willing to take a daily zinc supplement.

Willing to provide blood and urine samples

I am between 21 and 64 years old.

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant during the study.

I am not willing to stop taking zinc supplements or multivitamins during the study.

I have been diagnosed with a copper processing disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurements

Baseline experimental measurements collected at 0 and 3 months

3 months

2 visits (in-person)

Treatment

Participants receive zinc supplementation (zinc picolinate 15 mg once per day) for 6 months

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Zinc Picolinate 15 Mg

Trial Overview

The study investigates the impact of taking a daily dose of Zinc Picolinate (15 Mg) on reducing signs of metal toxicity in DNA and immune system disorders among Navajo Nation members exposed to metals.

How Is the Trial Designed?

Group I: Single-arm cohort Experimental Treatment 1 Intervention

Baseline experimental measurements will be collected for each individual participant twice prior to zinc supplementation (0 month and 3 month time points). After zinc supplementation, experimental measurements will be collected for each individual participant at the 6 month and 9 month time points. The zinc intervention is zinc picolinate 15 mg once per day for 6 months.

Zinc Picolinate 15 Mg is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Zinc Picolinate for:

• Zinc deficiency
• Supports immune system function
• Skin, hair, and nail health
• Reproductive health
• Antioxidant properties

Approved in European Union as Zinc Picolinate for:

• Zinc deficiency
• Supports immune system function
• Skin, hair, and nail health
• Reproductive health
• Antioxidant properties

Approved in Canada as Zinc Picolinate for:

• Zinc deficiency
• Supports immune system function
• Skin, hair, and nail health
• Reproductive health
• Antioxidant properties

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Published Research Related to This Trial

Picolinic acid enhances the efflux of various divalent metal ions, including zinc, from liposomes, suggesting it may influence the absorption and metabolism of these metals in the body.

The study indicates that picolinic acid does not function as an ionophore; instead, its effects on zinc metabolism are likely due to its ability to chelate multiple metal ions, potentially affecting their dietary and systemic distribution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in vitro study of the effect of picolinic acid on metal translocation across lipid bilayers. Aggett, PJ., Fenwick, PK., Kirk, H.[2018]

In a year-long study involving elderly participants (aged 60-89), supplementation with 100 mg of zinc daily significantly increased plasma zinc levels but did not enhance zinc concentrations in immune cells, indicating limited cellular uptake.

While zinc supplementation improved natural killer cell activity, it also showed an adverse effect on delayed dermal hypersensitivity, suggesting that zinc's impact on immune function can vary depending on the specific immune response being measured.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of one year of supplementation with zinc and other micronutrients on cellular immunity in the elderly. Bogden, JD., Oleske, JM., Lavenhar, MA., et al.[2019]

Approximately 30% of elderly individuals in developed countries are zinc deficient, which may contribute to chronic diseases linked to inflammation and oxidative stress.

Zinc supplementation in the elderly has been associated with reduced infections, lower oxidative stress, decreased inflammatory cytokines, and improved outcomes in conditions like age-related macular degeneration and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc: an antioxidant and anti-inflammatory agent: role of zinc in degenerative disorders of aging. Prasad, AS.[2014]

In a study of 97 patients with cirrhosis and hypozincemia, treatment with zinc acetate hydrate led to high rates of serum zinc normalization, with 82.5% achieving target levels after 6 months.

While the treatment effectively normalized zinc levels and improved some symptoms, 7.2% of patients discontinued due to hypocupremia, highlighting the need for monitoring copper levels during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of treatment with zinc acetate hydrate in patients with liver cirrhosis complicated by zinc deficiency. Ozeki, I., Nakajima, T., Suii, H., et al.[2020]

In a double-blind, placebo-controlled trial involving 73 patients with a zinc-deficiency taste disorder, zinc picolinate did not show significant improvement in subjective taste symptoms but did lead to measurable improvements in taste assessment using the filter paper disk method.

Patients receiving zinc picolinate had significantly higher serum zinc levels compared to the placebo group, suggesting that while subjective symptoms may not improve, zinc supplementation can enhance objective taste function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind, placebo-controlled trial of zinc picolinate for taste disorders. Sakai, F., Yoshida, S., Endo, S., et al.[2022]

Zinc supplements, when given for 10-14 days alongside low-osmolarity oral rehydration solution, significantly reduce the duration of acute diarrhea in children aged 6 months and older, with potential to lower diarrhea mortality by 23%.

Zinc is safe for children but may cause increased vomiting, particularly with the first dose; it also shows promise in reducing pneumonia incidence by about 19%, highlighting the need for accelerated national programs to address childhood zinc deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc supplementation in public health. Penny, ME.[2013]

Zinc supplementation significantly reduces the incidence of diarrhea by 18% and pneumonia by 41%, highlighting its importance in improving immune function and resistance to infections, especially in children.

Zinc has been shown to decrease child mortality by over 50% in some studies, emphasizing the need for programs to increase zinc intake in populations with deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc and the risk for infectious disease. Fischer Walker, C., Black, RE.[2022]

BioZn-AAS, a zinc gluconate stabilized with glycine, showed comparable absorption rates to other zinc compounds in female rats and significantly higher absorption in male rats, indicating its potential effectiveness as a zinc supplement.

Toxicity studies revealed a high oral lethal dose (LD50) of 2000 mg/kg for females and 1900 mg/kg for males, suggesting that BioZn-AAS is safe for use in food fortification and dietary supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability, biodistribution, and toxicity of BioZn-AAS(1): a new zinc source. comparative studies in rats. Salgueiro, MJ., Zubillaga, MB., Lysionek, AE., et al.[2019]

In a study of 29,103 participants, mean daily total zinc intakes varied by age and gender, with adults averaging 13 mg and pregnant/lactating females averaging 22 mg, indicating higher needs during pregnancy and lactation.

The survey revealed that young children, adolescent females, and older adults are at the highest risk for inadequate zinc intake, with only 55.6% of the population meeting the recommended dietary allowance for zinc.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc intake of the U.S. population: findings from the third National Health and Nutrition Examination Survey, 1988-1994. Briefel, RR., Bialostosky, K., Kennedy-Stephenson, J., et al.[2018]

In a study involving 15 healthy volunteers, zinc picolinate significantly increased zinc levels in hair, urine, and erythrocytes compared to zinc gluconate, zinc citrate, and placebo, indicating better absorption of zinc when complexed with picolinic acid.

The study suggests that using zinc picolinate as a supplement may enhance zinc bioavailability in humans, which could be beneficial for those needing to increase their zinc levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative absorption of zinc picolinate, zinc citrate and zinc gluconate in humans. Barrie, SA., Wright, JV., Pizzorno, JE., et al.[2019]

Zinc supplementation is recommended for children with low dietary zinc intake, severe stunting, low plasma zinc levels, or persistent diarrhea, especially in developing countries where zinc deficiency is common during the complementary feeding period.

There is a need for more research on the acceptability and bioavailability of different zinc salts, as some can be poorly absorbed or cause side effects, and guidelines for dosing frequency and quantity are currently lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc and micronutrient supplements for children. Allen, LH.[2018]

Zinc is crucial for various bodily functions and can help prevent upper respiratory infections and diarrhea in malnourished children, especially in developing countries.

While zinc is generally safe at recommended doses, long-term high-dose use can lead to adverse effects such as suppressed immunity and copper deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc: an essential micronutrient. Saper, RB., Rash, R.[2022]

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