Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy

Vitamin D Deficiency Clinical Trial

— LSG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483026
• Other study ID #: LSGD1HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: January 12, 2020

Study information

• Verified date: January 2020
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 12, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Disorder of Bone Density and Structure, Unspecified
• Malnutrition
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Multi vitamin
Multi vitamin
• vitamin D
Vitamin D

Locations

Country	Name	City	State
Israel	Hadassah hebrew university medical center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

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