Disorder of Bone Density and Structure, Unspecified, Vitamin D Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMulti vitamin
Multi vitamin
DIETARY_SUPPLEMENTvitamin D
Vitamin D
Sponsors
Hebrew University of Jerusalem
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone mass density | 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
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D status after the surgery | 1 year | levels of vitamin D (ng/ml) and presence of vitamin D deficiency. |
| Vitamin B12 status after the surgery | 1 year | levels of vitamin B12 (pg/dl) and presence of vitamin B12 deficiency. |
| Weight loss after the surgery | 1 year | weight (kg), %excess weight loss ( %EWL). |
| Parathyroid hormone (PTH) status after the surgery | 1 year | levels of Parathyroid hormone (PTH) (pg/ml) |
| Folate status after the surgery | 1 year | levels of folate (ng/ml) and presence of folate deficiency. |
| Iron status after the surgery | 1 year | levels of iron (µg/dl) and presence of iron deficiency. |
Countries
Israel
Outcome results
None listed