Zinc Intervention Study
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Purpose
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 serum zinc levels and various T-cell mediated immune factors.
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 | Intervention | Phase |
|---|---|---|
|
Disorder of Immune Function |
Dietary Supplement: zinc supplementation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Zinc Intervention in Nursing Home Elderly |
- serum zinc concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- lymphocyte proliferation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | July 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 30mg/day zinc
30mg/day of zinc provided for 3 months to zinc deficient elderly
|
Dietary Supplement: zinc supplementation
30mg/day of zinc
Other Name: zinc was provided in the form of zinc gluconate
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Males and females ≥65 years of age.
- More than 6 months life expectancy, in the judgment of their study physician.
- Willing to be randomized to one of the treatment groups.
- Able to swallow pills.
- Not currently on antibiotics.
- Subjects consuming DRI levels of supplements and willing to replace their supplement with our control supplement.
- Supplements of calcium, vitamin D, and iron will be permitted.
- Willing to receive influenza vaccine.
Exclusion Criteria:
- Anticipated transfer or discharge within three months of enrollment.
- Bed- or room-bound continuously for the last three months.
- 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).
- Naso-gastric or other tube feeding.
- Long-term intravenous or urethral catheters (30 days).
- Presence of tracheostomy or chronically ventilator-dependent.
- 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.
- 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
More Information
No publications provided
| Responsible Party: | Tufts University |
| ClinicalTrials.gov Identifier: | NCT01599572 History of Changes |
| Other Study ID Numbers: | 8541 |
| Study First Received: | May 14, 2012 |
| Last Updated: | May 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tufts University:
|
zinc supplementation serum zinc concentration lymphocyte proliferation |
Additional relevant MeSH terms:
|
Zinc Trace Elements Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013