Effect of Zinc Supplementation on Serum Zinc Level in Nursing Home Elderly
Zinc Intervention in Nursing Home Elderly
1 other identifier
interventional
31
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 14, 2012
CompletedFirst Posted
Study publicly available on registry
May 16, 2012
CompletedMay 21, 2015
May 1, 2015
1.5 years
May 14, 2012
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum zinc concentration
3 months
Secondary Outcomes (1)
lymphocyte proliferation
3 months
Study Arms (1)
30mg/day zinc supplementation
EXPERIMENTAL30mg/day of zinc supplement provided for 3 months to zinc deficient elderly
Interventions
30mg/day of zinc in the form of zinc gluconate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- Boston Universitycollaborator
- Hebrew SeniorLifecollaborator
- Boston Medical Centercollaborator
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Simin N Meydani, DVM, PhD
HNRCA-tufts University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2012
First Posted
May 16, 2012
Study Start
July 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
May 21, 2015
Record last verified: 2015-05