Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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This study will examine the effect of providing a structured program of daily nutritional supplements for a 8 weeks of intervention prior to Sleeve Gastrectomy bariatric surgery on bone mass density status and formation of critical nutritional deficiencies years after the surgery.

Detailed Description
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The present study hypothesis holds that providing an adequate nutritional supplements program prior to the surgery, combined with postoperative monitoring, will significantly lower the incidence of nutritional deficiencies in patients undergoing Sleeve Gastrectomy surgery, and will reduce complications arising from these pre-operative deficiencies. The investigators plan to examine the effect of Vitamins supplementation prior to surgery on the status of postoperative deficiencies one year after the surgery. Evaluation of outcomes will be made based on the results of blood tests specified, and related tests of bone density.

Official Title
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Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy: Controlled Clinical Study

Conditions
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Disorder of Bone Density and Structure, Unspecified, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Multi vitamin
* Dietary Supplement: vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for bariatric surgery BMI over 35 kg / m 2 accompanying morbidity or BMI over 40 kg / m 2, pre-operative evaluation standards with matching to carry sleeve gastrectomy surgery Vitamin D deficiency prior to surgery Exclusion Criteria: patients who underwent bariatric surgery in the past psychiatric or mentally contraindication for the procedure lack of consent to follow-up endocrine problem that affects the weight that is unbalanced. Chronic kidney disease (CKD), nephrolithiasis Hypercalcaemia Hypercalciuria and renal stones nephrolithiasis Pregnancy, breastfeeding Using medications or disease condition known as affecting the status of calcium or bone metabolism 3 month prior to intervention Taking any nutritional supplements 2 weeks before the study.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive supplements care pre-surgery<br>Multi vitamins pills vitamin D | Dietary Supplement: Multi vitamin<br>* Multi vitamin<br>Dietary Supplement: vitamin D<br>* Vitamin D<br>|
| Other: Standard supplements care pre-surgery<br>vitamin D (Vitamin D will be given in a reduced doses compared to the intervention group) | Dietary Supplement: vitamin D<br>* Vitamin D<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mass density | Status bone density one year after surgery will be measured by bone density test (DXA = X-ray dual energy absorptiometry) in units of g / cm2. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss after the surgery | weight (kg), %excess weight loss ( %EWL). | 1 year | 
| Vitamin D status after the surgery | levels of vitamin D (ng/ml) and presence of vitamin D deficiency. | 1 year | 
| Vitamin B12 status after the surgery | levels of vitamin B12 (pg/dl) and presence of vitamin B12 deficiency. | 1 year | 
| Iron status after the surgery | levels of iron (µg/dl) and presence of iron deficiency. | 1 year | 
| Parathyroid hormone (PTH) status after the surgery | levels of Parathyroid hormone (PTH) (pg/ml) | 1 year | 
| Folate status after the surgery | levels of folate (ng/ml) and presence of folate deficiency. | 1 year |