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NCT Number: NCT02483026

Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

Disorder of Bone Density and Structure, Unspecified Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah hebrew university medical center

Jerusalem, 91120, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi vitamin

Dietary Supplement

Multi vitamin

Vitamin D

Dietary Supplement

Vitamin D

Primary outcomes

  1. bone mass density

    Time frame: 1 year

    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 outcomes

  1. Weight loss after the surgery

    Time frame: 1 year

    weight (kg), %excess weight loss ( %EWL).

  2. Vitamin D status after the surgery

    Time frame: 1 year

    levels of vitamin D (ng/ml) and presence of vitamin D deficiency.

  3. Vitamin B12 status after the surgery

    Time frame: 1 year

    levels of vitamin B12 (pg/dl) and presence of vitamin B12 deficiency.

  4. Iron status after the surgery

    Time frame: 1 year

    levels of iron (µg/dl) and presence of iron deficiency.

  5. Parathyroid hormone (PTH) status after the surgery

    Time frame: 1 year

    levels of Parathyroid hormone (PTH) (pg/ml)

  6. Folate status after the surgery

    Time frame: 1 year

    levels of folate (ng/ml) and presence of folate deficiency.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Hebrew University of Jerusalem

Registry information

Official study title

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

Acronym: LSG

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 26, 2015
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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