Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy (LSG)

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Disorder of Bone Density and Structure, Unspecified
• Intervention / Treatment: Dietary supplement: Multi vitamin; Dietary supplement: vitamin D

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Hebrew University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Hebrew University of Jerusalem

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 12, 2020

Study Registration Dates

• First Submitted: April 18, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 26, 2015

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 12, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Musculoskeletal Diseases; Avitaminosis; Deficiency Diseases; Vitamin D Deficiency; Malnutrition; Bone Diseases; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Vitamin D; Vitamins
• Other Study ID Numbers: LSGD1HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No