Vitamin and Mineral Supplementation Post Bariatric Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Vitamin and Mineral Supplementation Post Bariatric Surgery: Sleeve Gastrectomy

Conditions
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Complications of Other Bariatric Procedure

Intervention / Treatment
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* Dietary Supplement: Vitamins and Minerals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A, 'vitamins and minerals'<br>Ergocalciferol , Vitamin B12, Calcium /D , Iron or Centrium. Ergocalciferol 300,000 IM - Every 3 months Oral Vitamin B12 tablets daily (500mcg) Calcium /D Tab 600-200mg Centrium -1 Tablet Daily Mineral: Iron preparation - Daily (47mg) | Dietary Supplement: Vitamins and Minerals<br>* Multivitamins and Minerals supplementation<br>|
| Active Comparator: Group B, 'vitamins and minerals'<br>Ergocalciferol , Vitamin B12, Calcium /D , Iron or Centrium. Centrium - 1 Tablet daily Ergocalciferol 50000 IU once every two weeks Vitamin B12 1000mcg IM every three months Calcium /D Tab 600-200mg Minerals: Iron preparation - Daily (47mg) | Dietary Supplement: Vitamins and Minerals<br>* Multivitamins and Minerals supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitor the levels of micronutrients of Iron | Change in micronutrients level of Iron | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitor the levels of uric acid | Change in level of uric acid | 1year | 
| complications resulting from IM injections | Number of complications resulting from IM injections | 1 year | 
| monitor the levels of calcium | Change in level of calcium | 1 year | 
| monitor the levels of Vitamin A | Change in level of Vitamin A | 1 year | 
| monitor the levels of Vitamin D | Change in level of Vitamin D | 1 year | 
| monitor the levels of Serum folate | Change in level of Serum folate | 1 year | 
| monitor the levels of Vitamin B12 | Change in level of Vitamin B12 | 1 year | 
| monitor the levels of Serum methyl malonate | Change in level of Serum methyl malonate | 1 year |