Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy

NCT ID: NCT02483026

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2020-01-12

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intensive supplements care pre-surgery

Multi vitamins pills vitamin D

Group Type: EXPERIMENTAL

Multi vitamin

Intervention Type: DIETARY_SUPPLEMENT

Multi vitamin

vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D

Standard supplements care pre-surgery

vitamin D (Vitamin D will be given in a reduced doses compared to the intervention group)

Group Type: OTHER

vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D

Interventions

Multi vitamin

Multi vitamin

Intervention Type: DIETARY_SUPPLEMENT

vitamin D

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebrew University of Jerusalem

OTHER

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Ram Elazary

Head bariatric surgeon Hadassah Ein Cerem Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadassah hebrew university medical center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

LSGD1HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id