A Randomized Controlled Trial of Vitamin and Mineral Supplementation Post Bariatric Surgery: Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- monitor the levels of micronutrients of Iron
研究概览
简要总结
Bariatric surgery is emerging as an essential treatment option for the management of obesity and its associated comorbidities. Many patients present for surgery have pre-existing low blood vitamin levels, thus all bariatric surgical procedures compromise nutrition to varying extents, and may present potential threat of micronutrient deficiencies. Therefore, long term nutritional monitoring and follow-ups are vital components of all bariatric surgical patients. However, there are no current standard practices in United Arab Emirates (UAE) for the biochemical monitoring and replacement of essential micronutrients in patients undergoing bariatric surgery particularly the most performed Sleeve Gastrectomy. Medical practice guidelines recommend nutritional care however, the dose and route of administration supplementation after surgery based on randomized controlled trials is not yet established. Till tow no scientific study has been performed on monitoring vitamins and minerals levels following bariatric surgery among UAE population. Therefore, present study is aimed to determine the dose and route of administration of vitamins and minerals in improving the micronutrient deficiencies post-operatively. Two standard different dosage forms (oral /parenteral) of vitamins and minerals will be given to the patients who had undergone sleeve gastrectomy at Tawam Hospital. The dosages of the supplementations are within the international recommendations and patients will be followed up closely for a period of one year. The effect of nutritional deficiencies on micronutrient level and quality of life (QOL) will be assessed. This will help the medical practitioners to prove the optimal possible nutrition for patients.
详细描述
The study will be conducted in Tawam Hospital where patients come for their routine bariatric surgery. A written informed consent will be taken from all the patients willing to participate in the study. Patients would be informed about the objectives / goals of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-60 years;
- •No medical or psychiatric contraindications;
- •BMI>35 kg/m2 with co-morbidities or BMI > 40 kg/m2 prior to the bariatric surgery.
排除标准
- •• Documented severe micronutrient deficiency that require treatment
- •Documented poor compliance;
- •History of in concordance to medication;
- •Inflammatory bowel disease, malignant or debilitating medical conditions;
- •Known hemoglobinopathies or those diagnosed with pernicious anaemia;
- •Known history of kidney renal stones or history of hypercalcaemia;
- •Significant longstanding medical complications that affect micronutrient status;
- •Severe psychiatric illness;
- •Women who are lactating, pregnant or planning pregnancy.
结局指标
主要结局
monitor the levels of micronutrients of Iron
时间窗: 1 year
Change in micronutrients level of Iron
次要结局
- monitor the levels of calcium(1 year)
- complications resulting from IM injections(1 year)
- monitor the levels of Vitamin A(1 year)
- monitor the levels of Vitamin D(1 year)
- monitor the levels of Serum folate(1 year)
- monitor the levels of uric acid(1year)
- monitor the levels of Serum methyl malonate(1 year)
- monitor the levels of Vitamin B12(1 year)
研究者
Juma Alkaabi
Professor, College of Medicine and Health Sciences
United Arab Emirates University