Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving

University of Toronto0 个研究点目标入组 45 人开始时间: 2004年11月最近更新: 2008年11月13日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: University of Toronto
入组人数: 45
主要终点: Serum 25-hydroxyvitamin D response

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3.

Objective: We wanted to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vitamin D3.

详细描述

Methods: In a single-arm design, 45 nursing-home residents consumed one bun/d that had been fortified with 125 mcg (5,000 IU) of vitamin D3 and 320 mg elemental calcium.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 58 Years 至 89 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy seniors in an institution in Romania

排除标准

•Known hypercalcemic or hypercalciuric disease

结局指标

主要结局

Serum 25-hydroxyvitamin D response

时间窗: 12 months

次要结局

Effects on serum calcium(12 months)
Effects on urine calcium(12 months)
Change in spine and hip bone mineral density, baseline vs final(12 months)
Change in parathyroid hormone, baseline vs final(12 months)

研究者

发起方

University of Toronto

申办方类型

Other

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