Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Percentage of subjects with deficiencies
研究概览
简要总结
Patients undergoing bariatric surgery often develop new vitamin and/or mineral deficiencies or exacerbate prior deficiencies after surgery. Several bariatric supplement products exist including oral tablets and transdermal patches. The purpose of this study is to observe the concentrations of serum micronutrients and determine how many deficiencies develop in patients who use a transdermal patch.
详细描述
Patients will undergo either a sleeve gastrectomy or gastric bypass procedure. All patients enrolled will have previously chosen to use the Patch MD MultiVitamin Plus patch for vitamin and mineral supplementation versus oral or other dosage forms of vitamins after surgery. A conversation between the patient and provider will occur first during a pre operative appointment, at which time the patient will be presented with the option to use oral vitamins or the Patch MD MultiVitamin Plus patch after surgery. Only if the patient chooses the patch will he/she be made aware of the study and recruited. Pre operative blood draws will be used to determine baseline micronutrient serum concentrations and existing deficiencies. The Gastrointestinal Symptom Rating Scale (GSRS) will be used pre operatively to determine baseline gastrointestinal symptoms. Post operative blood draws and GSRS data will be collected at 3 months, 6 months, and 1 year after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Candidates for a sleeve gastrectomy or gastric bypass surgery
- •Willingness and ability to provide informed consent in English
- •Commitment to the 1 year study period
排除标准
- •Planned bariatric revision surgery
- •Patients with a left ventricular assistance device
- •Known End Stage Renal Disease
- •Known mutation in methylenetetrahydrofolate reductase (MTHFR) gene
- •Medical conditions requiring vitamin and mineral supplementation
结局指标
主要结局
Percentage of subjects with deficiencies
时间窗: 1 year
The primary end point is the percentage of participants who have two or more deficiencies of vitamins B1, B6, B12, folate, D, zinc, calcium, copper, and iron one year after bariatric surgery after using the Patch MD™ MultiVitamin Plus transdermal patch for supplementation.
次要结局
- Thiamine(1 year)
- Pyridoxine(1 year)
- Folate(1 year)
- Zinc(1 year)
- Constipation syndrome(1 year)
- Methylcobalamin(1 year)
- Vitamin D(1 year)
- Calcium(1 year)
- Diarrhea syndrome(1 year)
- Copper(1 year)
- Iron(1 year)
- Ferritin(1 year)
- Parathyroid hormone(1 year)
- Indigestion syndrome(1 year)
- Acid reflux syndrome(1 year)
- Abdominal pain syndrome(1 year)
- Total iron binding capacity(1 year)