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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007143 |
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Date of registration:
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14/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prevention of hypocalcemia, vitamin D deficiency and secondary hyperparathyroidism in patients after laparoscopic sleeve gastrectomy by supplementation of vitamin D
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Scientific title:
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Prevention of hypocalcemia, vitamin D deficiency and secondary hyperparathyroidism in patients after laparoscopic sleeve gastrectomy by supplementation of vitamin D |
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Date of first enrolment:
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03/06/2013 |
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Target sample size:
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94 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00007143 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: parallel; Study design purpose: prevention
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Eva
Wolf |
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Address:
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Dorstener Str. 151
45657
Recklinghausen
Germany |
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Telephone:
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02361-56 83129 |
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Email:
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wolf-eva@web.de |
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Affiliation:
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Klinikum Vest GmbH |
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Name:
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Eva
Wolf |
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Address:
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Dorstener Str. 151
45657
Recklinghausen
Germany |
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Telephone:
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02361-56 83129 |
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Email:
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wolf-eva@web.de |
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Affiliation:
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Klinikum Vest GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Indication for sleeve-gastrectomy according to the current S3-guideline "Surgery of Obesity" (CA-ADIP, 2010): BMI > 40 kg/m2 after exhausting conservative treatment methods, or BMI > 35 kg/m2 with one or more obesity-associated comorbidities exhaustion of conservative treatment methods
• Written informed consent
• Voluntary participation
Exclusion criteria: • Previous surgery of the stomach
• Malignancies and chronic diseases such as liver cirrhosis
• Unstable psychopathological states, active substance dependence, and untreated bulimia nervosa
• Known pregnancy or lactation
• Ingestion of dietary supplements (e.g., vitamins)
• Hypercalcaemia
• Kidney stones
• Mental illness, cast doubt on the ability to understand business-capacity.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Laporoscopic Sleeve-Gastrectomy
E66
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Obesity
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Intervention(s)
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Group 1: Patients assigned to the vitamin D group supplemented 80 µg vitamin D3 by an oily suspension for 12 weeks (wk) once daily. This suspension was prepared by diluting Vigantol oil ® with Miglyol 812 ® (both from Merck, Darmstadt, Germany).
Group 2: Morbidly obese patients received a placebo in a randomized, double-blind manner for 12 weeks (wk) after SG. This placebo contains Miglyol 812 ®, a colorless oil of middle chain triglycerides (Merck, Darmstadt, Germany).
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Primary Outcome(s)
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Serum 25-OHD-concentration.
Serum 25-OHD was measured using an ELISA kit (IDS, Frankfurt/Main, Germany) at baseline and 4 and 12 weeks after bariatric surgery.
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Secondary Outcome(s)
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Laboratory values:
- PTH (IMMULITE 2000 Intact PTH),
- calcium, phosphat, magnesium (photometry)
- alkaline phosphatase, creatinine, albumin, CRP, HbA1c, glucose, cholesterol, HDL, LDL, triglycerides (routine clinical chemistry)
- TNF-alpha (ELISA)
- retinol, ascorbic acid, tocopherol, ß-carotene (HPLC).
Blood analysis was done at baseline and 4 and 12 weeks after surgery.
Antrophometric data:
Body height (at baseline) and Body weight (at baseline, 4 and 12 weeks after surgery)
Nutritional intake:
3 day food records at baseline and 3 and 11 weeks after surgery. The daily intake of energy, macronutrients, and vitamin D was calculated using DGE-PC professional software, version 4.0, based on the German Nutrient Data Base (BLS, Bundeslebensmittelschlussel) II.3.
Quality of life:
BAROS-questionnaire at baseline and 4 and 12 weeks after surgery (B.A.R.O.S. = Bariatric reporting and outcome system)
Compliance
The patients were asked to document the intake of the oily preparations in a pre-build diary which allowed us to determine the total amount of preparations ingested during intervention. All patients received the same number of single-dose ophtiols and were requested to bring the remaining ophtiols back. The number of ingested preparations was additionally determined as difference between provided and returned single-dose ophtiols in wk4 and wk12.
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Source(s) of Monetary Support
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Institut für Ernährungs- und Lebensmittelwissenschaften, Ernährungsphysiologie Universität Bonn
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Klinikum Vest GmbH
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Ethics review
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Status: Approved
Approval date: 15/04/2013
Contact:
ethik-kommission@aekwl.de
Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster
+49-251-9292460
ethik-kommission@aekwl.de
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