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

Hadassah Medical Center

Status: Completed

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

Treatments: Dietary Supplement: Multi vitamin; Dietary Supplement: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT02483026

LSGD1HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Intensive supplements care pre-surgery

Experimental group

Description:

Multi vitamins pills vitamin D

Treatment:

Dietary Supplement: Multi vitamin

Dietary Supplement: vitamin D

Standard supplements care pre-surgery

Other group

Description:

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

Treatment:

Dietary Supplement: vitamin D