search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Multi vitamin
vitamin D
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Disorder of Bone Density and Structure, Unspecified

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah hebrew university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intensive supplements care pre-surgery

Standard supplements care pre-surgery

Arm Description

Multi vitamins pills vitamin D

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2015
Last Updated
January 12, 2020
Sponsor
Hadassah Medical Organization
Collaborators
Hebrew University of Jerusalem
search

1. Study Identification

Unique Protocol Identification Number
NCT02483026
Brief Title
Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy
Acronym
LSG
Official Title
Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy: Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
January 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Hebrew University of Jerusalem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Bone Density and Structure, Unspecified, Vitamin D Deficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive supplements care pre-surgery
Arm Type
Experimental
Arm Description
Multi vitamins pills vitamin D
Arm Title
Standard supplements care pre-surgery
Arm Type
Other
Arm Description
vitamin D (Vitamin D will be given in a reduced doses compared to the intervention group)
Intervention Type
Dietary Supplement
Intervention Name(s)
Multi vitamin
Intervention Description
Multi vitamin
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
Vitamin D
Primary Outcome Measure Information:
Title
bone mass density
Description
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 Outcome Measure Information:
Title
Weight loss after the surgery
Description
weight (kg), %excess weight loss ( %EWL).
Time Frame
1 year
Title
Vitamin D status after the surgery
Description
levels of vitamin D (ng/ml) and presence of vitamin D deficiency.
Time Frame
1 year
Title
Vitamin B12 status after the surgery
Description
levels of vitamin B12 (pg/dl) and presence of vitamin B12 deficiency.
Time Frame
1 year
Title
Iron status after the surgery
Description
levels of iron (µg/dl) and presence of iron deficiency.
Time Frame
1 year
Title
Parathyroid hormone (PTH) status after the surgery
Description
levels of Parathyroid hormone (PTH) (pg/ml)
Time Frame
1 year
Title
Folate status after the surgery
Description
levels of folate (ng/ml) and presence of folate deficiency.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hadassah hebrew university medical center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy

We'll reach out to this number within 24 hrs