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临床试验/NCT01399164
NCT01399164已完成不适用

Cobalamin Absorption From Fortified Food in Older Adults With and Without Proton Pump Inhibitor Induced Achlorhydria

USDA, Western Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
B12 bioavailability

研究概览

简要总结

To determine B12 bioavailability from 14C-B12 fortified bread in healthy subjects and in subjects with proton pump inhibitor induced achlorhydria.

详细描述

Cobalamin (vitamin B12) deficiency is highly prevalent in the US and worldwide. Deficiency is most common in the elderly, with an average prevalence ≈25% over age 60 y. About 40% of older persons with low serum cobalamin have food cobalamin malabsorption (F-CM), in which gastric atrophy/achlorhydria and/or dysfunction is implicated. Because of the prevalence of deficiency in those over age 60 y, it is generally recommended that the elderly consume a higher proportion of their cobalamin from fortified foods than what is recommended for younger people. However there is considerable debate about whether crystalline cobalamin is absorbed as well by the elderly with F-CM as it is by younger people, especially if it is added as a fortificant to food. The data to be collected in this study will provide information useful to on-going deliberations concerning the future fortification of wheat flour with vitamin B12 in the United States.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • good overall health
  • normal absorptive capacity (controls) or with a serum B12 <300 pg/mL and a pepsinogen I level >100 μg/L (ACs).
  • All subjects must be available to complete the protocol

排除标准

  • Any chronic health disorder
  • Anemia of any kind
  • Renal insufficiency
  • excessive alcohol consumption
  • Prior GI surgery
  • Use of OTC or prescription drugs that interfere with B-12 absorption or metabolism
  • Use of vitamin supplements
  • Pregnancy or lactation

结局指标

主要结局

B12 bioavailability

时间窗: 8 Days

B12 bioavailability from 14C-B12 fortified bread

次要结局

未报告次要终点

研究者

发起方
USDA, Western Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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