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临床试验/NCT01475617
NCT01475617已完成2 期

Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients

Yasoo Health2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Plasma vitamin and mineral levels

研究概览

简要总结

Approximately 33% of the US adult population can be classified as obese based on body mass index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed every year for the treatment of "clinically severe obesity". Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed in the United States and has both restrictive and malabsorptive components. Despite the success of this procedure in creating long lasting weight loss, vitamin and iron deficiencies are common and can lead to significant morbidity if not appropriately addressed. Despite the American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation recommendations, there has been very little prospective research conducted to assess the efficacy and compliance of these micronutrient interventions.

This prospective randomized controlled clinical study will evaluate the efficacy of a novel vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative bariatric patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 - 65 years of age
  • Meet appropriate criteria for Roux-en-Y gastric bypass (RYGB) surgery as determined by the Principal Investigator at The John's Hopkins Center for Bariatric Surgery (JHCBS)

排除标准

  • Allergy to a component of the formulations
  • Recent (last 3 months) use of a dietary supplement other than a standard non-bariatric specific multivitamin supplement
  • Documented levels of fat-soluble vitamins (A,D,E,K) or iron above the normal range
  • Pregnant or lactating
  • Expected poor compliance with medical regimen as assessed by JHCBS clinic care providers

结局指标

主要结局

Plasma vitamin and mineral levels

时间窗: 3 and 6 months compared to baseline

次要结局

  • Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule(6 months)

研究者

发起方
Yasoo Health
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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Efficacy of a Novel Multivitamin-Mineral Supplement... | 临床试验