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

Maria Luger

Status and phase: Completed; Phase 4

Conditions: Bariatric Surgery Candidate

Treatments: Drug: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT02092376

LOAD

2013-003546-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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)

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo