Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Disorder of Bone Density and Structure, Unspecified
• Interventions: Dietary Supplement: Multi vitamin; Dietary Supplement: vitamin D

• Registration Number: NCT02483026
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-04-18
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-26
• Study Start: 2018-01-02
• Primary Completion: 2019-12-01
• Status Verified: 2020-01
• Study Completion: 2020-01-12
• Last Update Submitted: 2020-01-12
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive supplements care pre-surgery	Multi vitamin	Multi vitamins pills vitamin D
Intensive supplements care pre-surgery	vitamin D	Multi vitamins pills vitamin D
Standard supplements care pre-surgery	vitamin D	vitamin D (Vitamin D will be given in a reduced doses compared to the intervention group)

Primary Outcome Measures

Name	Time	Method
bone mass density	1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah hebrew university medical center; 🇮🇱 Jerusalem, Israel