Bariatric Surgery CandidatePhase 4LOADNCT02092376
The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery
A Phase 4 study testing Cholecalciferol in people with Bariatric Surgery Candidate, run by Maria Luger at 1 site in Austria.
Trial summary
The aim of the study is to increase vitamin D concentrations or to keep it on high level, respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the overall health status in bariatric patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2014to Jun 2016
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned omega loop bypass surgery
- 25-hydroxy vitamin D < 75 nmol/l
- BMI >40 or ≥35 kg/m2 with co-morbidities e.g. diabetes mellitus, hypertension
- Body weight <140 kg (due to limitation of DEXA measurement)
- Capability to consent
Who cannot join
- Another planned form of bariatric surgery
- Hypercalcemia (calcium >2.63 mmol/l) or hypocalcemia (<1.75 mmol/l)
- Renal insufficiency (creatinine >133 μmol/l or GFR <50 ml/min)
- Primary hyperparathyroidism
- Malignancy
- Infection e.g. human immunodeficiency virus
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- Medical conditions requiring daily calcium supplements or antacid use
- Known hypersensitivity to cholecalciferol
- No capability to consent
- Imprisoned persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery: a Randomized Controlled, Double-blinded Clinical Supplementation Trial
The aim of the study is to increase vitamin D concentrations or to keep it on high level, respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the overall health status in bariatric patients. In this project, the vitamin D status, the parameters of inflammation, bone turnover, insulin resistance, liver and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Bariatric surgery, vitamin D, supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | The loading dose of 300 000 IU is divided into three doses (100 000 IU) and will be given over the first months. All patients in the intervention group will receive the first loading dose of 100 000 IU at day of discharge. The second (2 weeks) and third (4 weeks postoperative) administration will be given based on the 25-hydroxy vitamin D concentration. After the last respectively third loading dose a maintenance dose of 3420 IU per day should maintain the high 25-hydroxy vitamin D concentration. It should be administered for up to 46 weeks (until follow-up visit) Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | The placebo loading dose (oil) is divided into three administrations and will be given over the first months. All patients in the placebo group will receive the first placebo loading dose at day of discharge. After the last placebo loading dose a maintenance dose of 3420 IU per day should maintain the 25-hydroxy vitamin D concentration. It should be administered for up to 46 weeks (until follow-up). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-hydroxy vitamin D levels
25-hydroxy vitamin D levels after 24 weeks measured in intervention and placebo group, adjusting for the baseline value as covariate
Measured: 24 weeks postoperatively
Secondary outcomes (13)
Prevalence of sufficient vitamin D
Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l
Measured: 24 weeks postoperatively
Prevalence of vitamin D deficiency
Prevalence of vitamin D deficiency
Measured: 24 weeks postoperatively
Co-morbidities
Prevalence of Co-morbidities
Measured: 24 weeks postoperatively
Prescribed medication
Change in prescribed medication
Measured: 24 weeks postoperatively
Body weight, body composition
Change in body weight and body composition by bioelectrical impedance analysis
Measured: 24 weeks postoperatively
Blood pressure
Change of vital signs (blood pressure)
Measured: 24 weeks postoperatively
Laboratory parameters
Change in laboratory parameters compared to baseline: vitamin D status, bone turnover markers, calcium homeostasis, parathyroid hormone, inflammation, insulin resistance
Measured: 24 weeks postoperatively
Depression symptoms
Prevalence of depression symptoms assessed by Beck Depression Inventory Questionnaire
Measured: 24 weeks postoperatively
Bone mineral density and body fat content
Assessment of bone mineral density and total body fat content by DEXA
Measured: 24 weeks postoperatively
Liver condition
Measurement of liver stiffness and fat content by FibroScan and CAP
Measured: 24 weeks postoperatively
Dietary assessment
Dietary assessment will be documented with a 5-day food record to calculate vitamin D intake and the Mediterranean Score (questionnaire with calculated score)
Measured: 24 weeks postoperatively
Gut microbiota composition
Association between vitamin D, gut microbiota and surgery-induced weight loss, by collecting stool samples
Measured: 24 weeks postoperatively
Vitamin D in adipose and liver tissue
For instance, for the purposes of describing adipose depot vitamin D concentrations and expression of enzymes in subcutaneous, visceral adipose and liver tissue samples will be collected during the omega loop gastric bypass surgery. Furthermore, the liver tissue samples should be used in addition for a histological examination as extended diagnostics (NAFLD/ NASH).
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Luger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Luger, Medical University of Vienna
- Investigators
- Bernhard Ludvik, M.D., Principal investigator, Division of Endocrinology & Metabolism, Department of Internal Medicine III, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092376
- Sponsor's protocol ID
- LOAD
- Other IDs
- 2013-003546-16
- Acronym
- LOAD
- Status last verified
- Jul 2016
- First submitted
- 17 Mar 2014
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chakhtoura MT, Nakhoul NF, Akl EA, Safadi BY, Mantzoros CS, Metzendorf MI, El-Hajj Fuleihan G. Oral vitamin D supplementation for adults with obesity undergoing bariatric surgery. Cochrane Database Syst Rev. 2024 Oct 1;10(10):CD011800. doi: 10.1002/14651858.CD011800.pub2.
PubMed 39351881Kruschitz R, Wakolbinger M, Schindler K, Prager G, Hoppichler F, Marculescu R, Ludvik B. Effect of one-anastomosis gastric bypass on cardiovascular risk factors in patients with vitamin D deficiency and morbid obesity: A secondary analysis. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2379-2388. doi: 10.1016/j.numecd.2020.08.011. Epub 2020 Aug 20.
PubMed 32981799Luger M, Kruschitz R, Winzer E, Schindler K, Grabovac I, Kainberger F, Krebs M, Hoppichler F, Langer F, Prager G, Marculescu R, Ludvik B. Changes in Bone Mineral Density Following Weight Loss Induced by One-Anastomosis Gastric Bypass in Patients with Vitamin D Supplementation. Obes Surg. 2018 Nov;28(11):3454-3465. doi: 10.1007/s11695-018-3353-2.
PubMed 29968187Luger M, Kruschitz R, Kienbacher C, Traussnigg S, Langer FB, Prager G, Schindler K, Kallay E, Hoppichler F, Trauner M, Krebs M, Marculescu R, Ludvik B. Vitamin D3 Loading Is Superior to Conventional Supplementation After Weight Loss Surgery in Vitamin D-Deficient Morbidly Obese Patients: a Double-Blind Randomized Placebo-Controlled Trial. Obes Surg. 2017 May;27(5):1196-1207. doi: 10.1007/s11695-016-2437-0.
PubMed 27837387Luger M, Kruschitz R, Kienbacher C, Traussnigg S, Langer FB, Schindler K, Wurger T, Wrba F, Trauner M, Prager G, Ludvik B. Prevalence of Liver Fibrosis and its Association with Non-invasive Fibrosis and Metabolic Markers in Morbidly Obese Patients with Vitamin D Deficiency. Obes Surg. 2016 Oct;26(10):2425-32. doi: 10.1007/s11695-016-2123-2.
PubMed 26989059Luger M, Kruschitz R, Marculescu R, Haslacher H, Hoppichler F, Kallay E, Kienbacher C, Klammer C, Kral M, Langer F, Luger E, Prager G, Trauner M, Traussnigg S, Wurger T, Schindler K, Ludvik B. The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial. Trials. 2015 Aug 5;16:328. doi: 10.1186/s13063-015-0877-9.
PubMed 26242295
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery: a Randomized Controlled, Double-blinded Clinical Supplementation Trial
- ClinicalTrials.gov ID
- NCT02092376
- Acronym / sponsor ID
- LOAD / LOAD
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric surgery, vitamin D, supplementation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maria LugerUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Mar 2014 (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.
The aim of the study is to increase vitamin D concentrations or to keep it on high level, respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the overall health status in bariatric patients. In this project, the vitamin D status, the parameters of inflammation, bone turnover, insulin resistance, liver and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: CholecalciferolThe loading dose of 300 000 IU is divided into three doses (100 000 IU) and will be given over the first months. All patients in the intervention group will receive the first loading dose of 100 000 IU at day of discharge. The second (2 weeks) and third (4 weeks postoperative) administration will be given based on the 25-hydroxy vitamin D concentration. After the last respectively third loading dose a maintenance dose of 3420 IU per day should maintain the high 25-hydroxy vitamin D concentration. It should be administered for up to 46 weeks (until follow-up visit) |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo loading dose (oil) is divided into three administrations and will be given over the first months. All patients in the placebo group will receive the first placebo loading dose at day of discharge. After the last placebo loading dose a maintenance dose of 3420 IU per day should maintain the 25-hydroxy vitamin D concentration. It should be administered for up to 46 weeks (until follow-up). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Planned omega loop bypass surgery
- 25-hydroxy vitamin D < 75 nmol/l
- BMI >40 or ≥35 kg/m2 with co-morbidities e.g. diabetes mellitus, hypertension
- Body weight <140 kg (due to limitation of DEXA measurement)
- Capability to consent
Key exclusion criteria (10 listed)
- Another planned form of bariatric surgery
- Hypercalcemia (calcium >2.63 mmol/l) or hypocalcemia (<1.75 mmol/l)
- Renal insufficiency (creatinine >133 μmol/l or GFR <50 ml/min)
- Primary hyperparathyroidism
- Malignancy
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 |
|---|---|---|
| Cholecalciferol | Drug | Intervention |
| Placebo | Drug | Placebo |
Primary outcome
25-hydroxy vitamin D levels
Time frame: 24 weeks postoperatively
25-hydroxy vitamin D levels after 24 weeks measured in intervention and placebo group, adjusting for the baseline value as covariate
13 secondary outcomes
Prevalence of sufficient vitamin D
Time frame: 24 weeks postoperatively
Prevalence of vitamin D deficiency
Time frame: 24 weeks postoperatively
Co-morbidities
Time frame: 24 weeks postoperatively
Prescribed medication
Time frame: 24 weeks postoperatively
Body weight, body composition
Time frame: 24 weeks postoperatively
Blood pressure
Time frame: 24 weeks postoperatively
Laboratory parameters
Time frame: 24 weeks postoperatively
Depression symptoms
Time frame: 24 weeks postoperatively
Bone mineral density and body fat content
Time frame: 24 weeks postoperatively
Liver condition
Time frame: 24 weeks postoperatively
Dietary assessment
Time frame: 24 weeks postoperatively
Gut microbiota composition
Time frame: 24 weeks postoperatively
Vitamin D in adipose and liver tissue
Time frame: during surgery
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 Jul 2016.
- Derived from this study: PubMed 39351881Chakhtoura MT, Nakhoul NF, Akl EA, Safadi BY, Mantzoros CS, Metzendorf MI, El-Hajj Fuleihan G. Oral vitamin D supplementation for adults with obesity undergoing bariatric surgery. Cochrane Database Syst Rev. 2024 Oct 1;10(10):CD011800. doi: 10.1002/14651858.CD011800.pub2.
- Derived from this study: PubMed 32981799Kruschitz R, Wakolbinger M, Schindler K, Prager G, Hoppichler F, Marculescu R, Ludvik B. Effect of one-anastomosis gastric bypass on cardiovascular risk factors in patients with vitamin D deficiency and morbid obesity: A secondary analysis. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2379-2388. doi: 10.1016/j.numecd.2020.08.011. Epub 2020 Aug 20.
- Derived from this study: PubMed 29968187Luger M, Kruschitz R, Winzer E, Schindler K, Grabovac I, Kainberger F, Krebs M, Hoppichler F, Langer F, Prager G, Marculescu R, Ludvik B. Changes in Bone Mineral Density Following Weight Loss Induced by One-Anastomosis Gastric Bypass in Patients with Vitamin D Supplementation. Obes Surg. 2018 Nov;28(11):3454-3465. doi: 10.1007/s11695-018-3353-2.
- Derived from this study: PubMed 27837387Luger M, Kruschitz R, Kienbacher C, Traussnigg S, Langer FB, Prager G, Schindler K, Kallay E, Hoppichler F, Trauner M, Krebs M, Marculescu R, Ludvik B. Vitamin D3 Loading Is Superior to Conventional Supplementation After Weight Loss Surgery in Vitamin D-Deficient Morbidly Obese Patients: a Double-Blind Randomized Placebo-Controlled Trial. Obes Surg. 2017 May;27(5):1196-1207. doi: 10.1007/s11695-016-2437-0.
- Derived from this study: PubMed 26989059Luger M, Kruschitz R, Kienbacher C, Traussnigg S, Langer FB, Schindler K, Wurger T, Wrba F, Trauner M, Prager G, Ludvik B. Prevalence of Liver Fibrosis and its Association with Non-invasive Fibrosis and Metabolic Markers in Morbidly Obese Patients with Vitamin D Deficiency. Obes Surg. 2016 Oct;26(10):2425-32. doi: 10.1007/s11695-016-2123-2.
- Derived from this study: PubMed 26242295Luger M, Kruschitz R, Marculescu R, Haslacher H, Hoppichler F, Kallay E, Kienbacher C, Klammer C, Kral M, Langer F, Luger E, Prager G, Trauner M, Traussnigg S, Wurger T, Schindler K, Ludvik B. The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial. Trials. 2015 Aug 5;16:328. doi: 10.1186/s13063-015-0877-9.
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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.
Bernhard Ludvik, M.D. principal investigator
Division of Endocrinology & Metabolism, Department of Internal Medicine III, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with Bariatric Surgery Candidate, run by Maria Luger at 1 site in Austria.
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 5 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 Jul 2016. 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 Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
25-hydroxy vitamin D levels (time frame: 24 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02092376, which also lists 6 linked publications.
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 Jul 2016.