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.
|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 ]
|Study Start Date:||July 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599572
|Principal Investigator:||Simin N Meydani, DVM, PhD||HNRCA-tufts University|