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临床试验/NCT00153764
NCT00153764已完成1 期

Effectiveness of a One-a-Day Cooper Complete Vitamin / Mineral Supplement With or Without Omega-3 Fatty Acid Ingestion

The Cooper Institute1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
75
试验地点
1
主要终点
homocycsteine

研究概览

简要总结

The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete vitamin supplement with or without a combined omega-3 fatty acid supplement on selected clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

详细描述

Participants will be randomized to 1 of 3 groups: vitamin with omega-3, vitamin w/o omega-3, or omega-3 alone. They will take the vitamin 12 weeks, after which time they will return for all laboratory tests. Persons who are currently taking a supplement must undergo a 2-week washout period before beginning the study. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30-70 years of age, maintain current diet and exercise regimen, not currently taking vitamins or agree to stop for 6 weeks

排除标准

  • BMI <18.5 or >34.9, recent blood donation, elevated blood pressure, cholesterol, or fasting blood glucose that requires medication, plans to move soon, or pregnant or plans to become pregnant

研究组 & 干预措施

multivitamin

Placebo Comparator

1 tablet morning and evening

干预措施: Cooper Complete One-A-Day Vitamin Supplement (Drug)

结局指标

主要结局

homocycsteine

LDL cholesterol oxidation rate

次要结局

  • fasting plasma glucose
  • C-reactive protein

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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