NCT02092376

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2014

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

March 17, 2014

Last Update Submit

July 13, 2016

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric surgeryvitamin Dsupplementation

Outcome Measures

Primary Outcomes (1)

  • 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

    24 weeks postoperatively

Secondary Outcomes (13)

  • Prevalence of sufficient vitamin D

    24 weeks postoperatively

  • Prevalence of vitamin D deficiency

    24 weeks postoperatively

  • Co-morbidities

    24 weeks postoperatively

  • Prescribed medication

    24 weeks postoperatively

  • Body weight, body composition

    24 weeks postoperatively

  • +8 more secondary outcomes

Study Arms (2)

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)

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).

Drug: Placebo

Interventions

CholecalciferolDRUG
Intervention
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned omega loop bypass surgery
  • 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

You may not qualify if:

  • 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
  • Medical conditions requiring daily calcium supplements or antacid use
  • Known hypersensitivity to cholecalciferol
  • No capability to consent
  • Imprisoned persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (6)

  • 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.

    PMID: 39351881DERIVED

  • Kruschitz 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.

    PMID: 32981799DERIVED

  • Luger 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.

    PMID: 29968187DERIVED

  • Luger 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.

    PMID: 27837387DERIVED

  • Luger 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.

    PMID: 26989059DERIVED

  • Luger 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.

    PMID: 26242295DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Bernhard Ludvik, M.D.

    Division of Endocrinology & Metabolism, Department of Internal Medicine III, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Maria Luger, MSc

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Study Completion

June 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

AU(1)