Zinc Intervention in Nursing Home Elderly
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- serum zinc concentration
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
serum zinc concentration
时间窗: 3 months
次要结局
- lymphocyte proliferation(3 months)