Disorder of Bone Density and Structure, UnspecifiedLSGNCT02483026
Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy
A study testing Multi vitamin and vitamin D in people with Disorder of Bone Density and Structure, Unspecified and Vitamin D Deficiency, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Disorder of Bone Density and Structure, Unspecified, Vitamin D Deficiency
- What is being tested?
- Multi vitamin and vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Jan 2018to 12 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy: Controlled Clinical Study
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.
Read the 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.
- Being tested
- Multi vitamin, vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi vitaminDietary supplement
Multi vitamin
vitamin DDietary supplement
Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Intensive supplements care pre-surgery | Experimental | Multi vitamins pills vitamin D Receives: Dietary Supplement: Multi vitamin; Dietary 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) Receives: Dietary Supplement: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
Weight loss after the surgery
weight (kg), %excess weight loss ( %EWL).
Measured: 1 year
Vitamin D status after the surgery
levels of vitamin D (ng/ml) and presence of vitamin D deficiency.
Measured: 1 year
Vitamin B12 status after the surgery
levels of vitamin B12 (pg/dl) and presence of vitamin B12 deficiency.
Measured: 1 year
Iron status after the surgery
levels of iron (µg/dl) and presence of iron deficiency.
Measured: 1 year
Parathyroid hormone (PTH) status after the surgery
levels of Parathyroid hormone (PTH) (pg/ml)
Measured: 1 year
Folate status after the surgery
levels of folate (ng/ml) and presence of folate deficiency.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start2 Jan 2018
- Primary completion1 Dec 2019
- Study completion12 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Bone Density and Structure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Principal investigator, Ram Elazary, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483026
- Sponsor's protocol ID
- LSGD1HMO-CTIL
- Acronym
- LSG
- Status last verified
- Jan 2020
- First submitted
- 18 Apr 2015
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Deficiencies Preventive Treatment Prior to Laparoscopic Sleeve Gastrectomy: Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02483026
- Acronym / sponsor ID
- LSG / LSGD1HMO-CTIL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 12 Jan 2020 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive supplements care pre-surgery | Experimental | Dietary Supplement: Multi vitamin, Dietary Supplement: vitamin DMulti vitamins pills vitamin D |
| Standard supplements care pre-surgery | Other | Dietary Supplement: vitamin Dvitamin D (Vitamin D will be given in a reduced doses compared to the intervention group) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi vitaminMulti vitamin | Dietary supplement | Intensive supplements care pre-surgery |
| vitamin DVitamin D | Dietary supplement | Intensive supplements care pre-surgery, Standard supplements care pre-surgery |
Primary outcome
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.
6 secondary outcomes
Weight loss after the surgery
Time frame: 1 year
Vitamin D status after the surgery
Time frame: 1 year
Vitamin B12 status after the surgery
Time frame: 1 year
Iron status after the surgery
Time frame: 1 year
Parathyroid hormone (PTH) status after the surgery
Time frame: 1 year
Folate status after the surgery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi vitamin and vitamin D in people with Disorder of Bone Density and Structure, Unspecified and Vitamin D Deficiency, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mass density (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.