Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy

Hadassah Medical Organization62 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Disorder of Bone Density and Structure, Unspecified Vitamin D Deficiency

Interventions

Multi vitaminDIETARY_SUPPLEMENT

Multi vitamin

vitamin DDIETARY_SUPPLEMENT

Vitamin D

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hadassah hebrew university medical center

Jerusalem, Israel

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Weight loss after the surgery

weight (kg), %excess weight loss ( %EWL).

Time frame: 1 year

Vitamin D status after the surgery

levels of vitamin D (ng/ml) and presence of vitamin D deficiency.

Time frame: 1 year

Vitamin B12 status after the surgery

levels of vitamin B12 (pg/dl) and presence of vitamin B12 deficiency.

Time frame: 1 year

Iron status after the surgery

levels of iron (µg/dl) and presence of iron deficiency.

Time frame: 1 year

Parathyroid hormone (PTH) status after the surgery

levels of Parathyroid hormone (PTH) (pg/ml)

Time frame: 1 year

Folate status after the surgery

levels of folate (ng/ml) and presence of folate deficiency.

Time frame: 1 year

Data from ClinicalTrials.gov

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