NCT02483026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
2.5 years until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

April 18, 2015

Last Update Submit

January 12, 2020

Conditions

Disorder of Bone Density and Structure, UnspecifiedVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Weight loss after the surgery

    1 year

  • Vitamin D status after the surgery

    1 year

  • Vitamin B12 status after the surgery

    1 year

  • Iron status after the surgery

    1 year

  • Parathyroid hormone (PTH) status after the surgery

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Intensive supplements care pre-surgery

EXPERIMENTAL

Multi vitamins pills vitamin D

Dietary Supplement: Multi vitaminDietary Supplement: vitamin D

Standard supplements care pre-surgery

OTHER

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

Dietary Supplement: vitamin D

Interventions

Multi vitaminDIETARY_SUPPLEMENT

Multi vitamin

Intensive supplements care pre-surgery
vitamin DDIETARY_SUPPLEMENT

Vitamin D

Intensive supplements care pre-surgeryStandard supplements care pre-surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah hebrew university medical center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

GeritolVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head bariatric surgeon Hadassah Ein Cerem Medical Center

Study Record Dates

First Submitted

April 18, 2015

First Posted

June 26, 2015

Study Start

January 2, 2018

Primary Completion

December 1, 2019

Study Completion

January 12, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)