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Completed

NCT Number: NCT01599572

Effect of Zinc Supplementation on Serum Zinc Level 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zinc supplementation

Other

30mg/day of zinc in the form of zinc gluconate

Other names: zinc was provided in the form of zinc gluconate

Primary outcomes

  1. serum zinc concentration

    Time frame: 3 months

Secondary outcomes

  1. lymphocyte proliferation

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Boston Medical Center
  • Boston University
  • Hebrew SeniorLife

Registry information

Official study title

Zinc Intervention in Nursing Home Elderly

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 16, 2012
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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