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

May 19, 2015 updated by: Tufts University

Zinc Intervention in Nursing Home Elderly

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • zinc was provided in the form of zinc gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum zinc concentration
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
lymphocyte proliferation
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Collaborators

Boston University
Boston Medical Center
Hebrew SeniorLife

Investigators

  • Principal Investigator: Simin N Meydani, DVM, PhD, HNRCA-tufts University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimate)

May 16, 2012

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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