Effect of Zinc Supplementation on Serum Zinc Level in Nursing Home Elderly
Study Details
Study Description
Brief Summary
Background: Zinc supplementation has the potential to improve serum zinc levels and immunity of zinc deficient nursing home elderly.
Objective: To determine the effect of zinc supplementation of 30mg/d for 3 months on serum zinc levels and T-cell mediated function of zinc deficient nursing home elderly.
Design: This is a randomized, double-blind, placebo-controlled study. Outcome measures included change in serum zinc levels and various T-cell mediated immune factors between baseline and month 3.
Hypotheses: The investigators hypothesize that zinc supplementation of 30mg/d for 3 months will improve serum zinc levels as well as various T-cell mediated immune factors in zinc deficient nursing home elderly.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Four hundred and forty-two medical charts were screened from three participating nursing homes; 53 nursing home elderly were eligible and therefore were screened for low serum zinc levels (<70µg/dL). Of these, 31 (58%) had low serum zinc levels. Participants were randomized into either the placebo (N=16) or the zinc supplemented (N=15) group. Six participants did not complete the study for various reasons including refusal to take study capsules, and advice from their physicians; one participant in the zinc group experienced nausea on two consecutive days following ingestion of the zinc capsule at the beginning of the study. A total of 25 participants completed the study with 13 and 12 receiving the placebo and zinc capsules, respectively, over a period of three months
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 30mg/day zinc supplementation 30mg/day of zinc supplement provided for 3 months to zinc deficient elderly |
Other: zinc supplementation
30mg/day of zinc in the form of zinc gluconate
Other Names:
|
Outcome Measures
Primary Outcome Measures
- serum zinc concentration [3 months]
Secondary Outcome Measures
- lymphocyte proliferation [3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females ≥65 years of age.
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More than 6 months life expectancy, in the judgment of their study physician.
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Willing to be randomized to one of the treatment groups.
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Able to swallow pills.
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Not currently on antibiotics.
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Subjects consuming DRI levels of supplements and willing to replace their supplement with our control supplement.
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Supplements of calcium, vitamin D, and iron will be permitted.
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Willing to receive influenza vaccine.
Exclusion Criteria:
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Anticipated transfer or discharge within three months of enrollment.
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Bed- or room-bound continuously for the last three months.
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Presence of lung neoplastic diseases or other active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs (including no more than 10 mg/day of prednisone).
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Naso-gastric or other tube feeding.
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Long-term intravenous or urethral catheters (30 days).
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Presence of tracheostomy or chronically ventilator-dependent.
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Consuming supplements containing more than the DRI level of nutrients known to affect the immune response, i.e. vitamins E, C, B6, selenium, zinc, or β -carotene and unwilling to stop.
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Chronic prophylactic antibiotic treatment (low percent of subjects meeting other inclusion criteria). 9) Protein energy malnutrition defined as albumin < 3.0 g/dl and BMI <18 kg/m2.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tufts University
- Boston University
- Hebrew SeniorLife
- Boston Medical Center
Investigators
- Principal Investigator: Simin N Meydani, DVM, PhD, HNRCA-tufts University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8541