Effect of Zinc Supplementation on Serum Zinc Level in Nursing Home Elderly

This study has been completed.
Sponsor:
Collaborators:
Boston University
Hebrew Rehabilitation Center, Boston
Boston Medical Center
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01599572
First received: May 14, 2012
Last updated: May 19, 2015
Last verified: May 2015
  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 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 Intervention Phase
Disorder of Immune Function
Other: 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

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • serum zinc concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 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 Name: zinc was provided in the form of zinc gluconate

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females ≥65 years of age.
  2. More than 6 months life expectancy, in the judgment of their study physician.
  3. Willing to be randomized to one of the treatment groups.
  4. Able to swallow pills.
  5. Not currently on antibiotics.
  6. Subjects consuming DRI levels of supplements and willing to replace their supplement with our control supplement.
  7. Supplements of calcium, vitamin D, and iron will be permitted.
  8. Willing to receive influenza vaccine.

Exclusion Criteria:

  1. Anticipated transfer or discharge within three months of enrollment.
  2. Bed- or room-bound continuously for the last three months.
  3. 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).
  4. Naso-gastric or other tube feeding.
  5. Long-term intravenous or urethral catheters (30 days).
  6. Presence of tracheostomy or chronically ventilator-dependent.
  7. 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.
  8. 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01599572

Sponsors and Collaborators
Tufts University
Boston University
Hebrew Rehabilitation Center, Boston
Boston Medical Center
Investigators
Principal Investigator: Simin N Meydani, DVM, PhD HNRCA-tufts University
  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 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
zinc supplementation
serum zinc concentration
lymphocyte proliferation

Additional relevant MeSH terms:
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on September 03, 2015