The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

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)

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

Placebo

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Cholecalciferol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No