Set the pattern of vitamin D supplementation in obese patients undergoing bariatric surgery in deficit of vitamin D. Patients receive a single oral dose of vitamin D, during the 28 days will be done a kinetic curve. Then and over the next 3 months, levels are normalized. Once normalized, will be administered another single oral dose to a second pharmacokinetic evaluation. Intervention Model: Single Group AssignmentMasking: Open LabelPrimary Purpose: Treatment Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization Drug Information available for: Comparison of pharmacokinetic parameters [ Time Frame: 36 weeks ] Comparison of the pharmacokinetic parameters between the two types of surgery [ Time Frame: 36 weeks ] Proportion of patients with secondary hyperparathyroidism in both surgeries. [ Time Frame: 36 weeks ] Change from baseline levels of urinary excretion of calcium in both surgeries [ Time Frame: 36 weeks ]
Change from baseline levels of urinary excretion creatinine in both surgeries [ Time Frame: 36 weeks ] Change from baseline in both biochemistry surgery [ Time Frame: 36 weeks ] Change from baseline alkaline phosphatase levels in both surgeries [ Time Frame: 36 weeks ] Change from baseline body fat distribution by DEXA [ Time Frame: 36 weeks ] Changes adherence in both surgeries [ Time Frame: 36 weeks ] Incidence of adverse and clinical laboratory events for each of the surgeries [ Time Frame: 36 weeks ] Proportion of patients with serious adverse events related to medication [ Time Frame: 36 weeks ] Oral Cholecalciferol for pharmacokinetics determination: - VITAMIN D3 Kern Pharma mixed with chocolate or vanilla custard Standarization cholecalciferol dose depends on baseline levels as indicated below: - <10 2800 UI - 10-15 2000 UI - 15-20 1200 UI - 20-30 1000 UI The study is conducted in obese patients undergoing bariatric surgery (for bypass or sleeve gastrectomy) in deficit of vitamin D.
Will include a total of 44 patients, 22 from each type of surgery. Patients receive a single oral dose of vitamin D of 50,000 IU. During the 28 days after administration of vitamin D will be done a kinetic curve determining plasma levels of vitamin D on 15 occasions. Then and over the next 3 months, levels are normalized by providing a daily oral dose for each patient. Once levels are normalized, will be administered another single oral dose of 50,000 IU vitamin D and proceed to a second pharmacokinetic evaluation determining plasma levels 15 times. Patient follow up is approximately 36 weeks. Patients go to the screening visit, baseline visit and visits on days 1, 2, 3, 14 and 28 days after each pharmacokinetic evaluation. Ages Eligible for Study: 18 Years and older (Adult, Senior) Sexes Eligible for Study: 18 or more years old with bariatric surgery in the last 18 months (+/- 6 months) vitamin D3 (OK)<20ng/mL. Clinically stable, in the opinion of the investigator, at the time of inclusion Signed consent form Exclusion Criteria: pregnancy, lactation or intention during the study period. menopause GOP, GPT>2 UNL
glomerular filtration rate <60ml/min any digestive disease to suggest malabsorption, granulomatous diseases, diabetic gastroenteropathy and taking medication likely to interfere with the absorption of vitamin D and bone metabolism such as corticosteroids and anticonvulsants taking medication that interferes with calcium metabolism. other bariatric surgery (different of by-pass or tubular gastrectomy) Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. Please refer to this study by its ClinicalTrials.gov identifier: NCT01637155 Contact: Violeta Moize, MD +34 93 227 54 00 Hospital Clinic i Provincial Barcelona Contact: Violeta Moize, MD +34 93 227 54 00 vmoize@clinic.ub.es
Principal Investigator: Violeta Moize, MD Hospital Clinic i Provincial de Barcelona Other Study ID Numbers: Keywords provided by Hospital Clinic of Barcelona: Additional relevant MeSH terms: Physiological Effects of Drugs Bone Density Conservation AgentsGenerika Kern Pharma ist ein Referenzunternehmen für die Entwicklung, Herstellung und Vermarktung von Generika... Mehr lesen Biologics Biologics ist der Unternehmensbereich von Kern Pharma , der Biosimilars zum Schwerpunkt hat... Mehr lesen International Kern Pharma vertreibt seine Medikamente in über 50 Ländern weltweit. Es verfügt über eine Niederlassung... Mehr lesen Consumer Consumer ist der Unternehmensbereich, der sich auf die Vermarktung von pharmazeutisch empfohlenen... Mehr lesen Gynea Unter der Marke Gynea vermarktet Kern Pharma eine breite Palette an Produkten zur Optimierung der... Mehr lesen HERSTELLUNG FÜR DRITTANBIETER Kern Pharma genießt das Vertrauen von Großunternehmen der Branche, die es aufgrund seiner Zuverlässigkeit...
What you need to know Whether you choose to breastfeed or formula feed your baby you should give your baby 5 micrograms (5µg) of vitamin D3 every day. What is Vitamin D?Vitamin D is important because it helps our bodies use calcium to build and maintain strong bones and teeth. Children (and adults) in Ireland have low levels of vitamin D which can lead to weak bones. In severe cases low levels of vitamin D can cause rickets(1) in children. There has been an increase in the number of cases of rickets in Ireland in recent years. Vitamin D is known as the ‘sunshine vitamin’ because our bodies can make vitamin D from the sun. When sunlight hits our skin, the ultra-violet B (UVB) sun rays are used to make vitamin D. However, it is not possible for babies to safely get the vitamin D they need from the sun. Read Information for Health Professional on Vitamin D supplementation. Why does my baby need Vitamin D? Your baby needs vitamin D because: Babies with African, Afro-Caribbean, Middle- Eastern or Indian ethnic backgrounds are at even higher risk of having low levels of vitamin D.
Their stores of vitamin D may be particularly low when born as their mothers’ skin may not be as efficient at making vitamin D from the amount and type of sunlight in Ireland. I am pregnant and taking Vitamin D – will my baby still need to take Vitamin D after birth?All babies need vitamin D because they do not get enough from their food. This includes babies of mothers who took vitamin D while pregnant. Like all babies they will need to take vitamin D everyday to make up for the low level in their food. What type of Vitamin D should I give my baby?Vitamin D3 (cholecalciferol) is the preferred form of vitamin D for infants. The vitamin D3 product you use should be in a liquid form suitable for infants and contain only vitamin D3. Products that contain other vitamins as well as vitamin D (such as multivitamin products) should not be used. Why are we being asked to give our babies Vitamin D now?The evidence is that children and mothers in Ireland have low levels of vitamin D. Low levels of vitamin D leads to weak bones.
In severe cases low levels of vitamin D can cause rickets in children and osteomalacia(2) in adults. There have been a growing number of cases of rickets diagnosed in Ireland in recent years. Research is also showing that vitamin D plays an important role in helping the immune system. It may also help prevent illnesses like diabetes, heart disease, rheumatoid arthritis, multiple sclerosis as well as some forms of cancer. Recommendation: To ensure that ALL babies get enough vitamin D they should be given 5 micrograms (5μg) of vitamin D3 every day from birth to 12months, whether breastfed or formula fed or taking solid foods. The vitamin D product used should contain only Vitamin D3and be in a liquid form suitable for infants.If your doctor has already prescribed vitamins for your baby you should ask their advice before giving your baby any additional vitamin products. What dosage should I give my baby?The current recommendation is 5 micrograms (5μg) once a day – from birth to 12 months.
There are a number of suitable infant vitamin D3 products available to buy in Ireland. These provide the correct kind of vitamin D3. Important: The number of drops or amount of liquid required to give your baby the recommended 5 micrograms (5μg) daily is different for each product. Read the product instructions carefully and ask your pharmacist, doctor, dietitian or nurse for advice if needed. Very large doses of vitamin D3 may make your baby ill. Only one dose per day should be given. How do I give my baby the Vitamin D?Check the product label for the number of drops or amount of liquid you need to give your baby. The correct amount is 5 micrograms (5μg). Give your baby the correct dose directly into their mouth. Are there any risks if I give my baby too much Vitamin D3?Very high amounts of vitamin D are harmful. The recommended 5 micrograms (5μg) vitamin D a day is very safe for babies. Harmful effects only begin at levels that are five times higher than this recommended dose.
You need to follow the manufacturer’s instructions and give the correct dose. If the vitamin D3 product is given in the correct amount (according to the manufacturer’s instructions) there are no risks to babies. Giving the correct amount is very important. If you forget to give your baby their daily Vitamin D3, then start again the next day but do not give more than one dose per day. Where can I get Vitamin D3?Vitamin D3 products suitable for babies are food supplements so you don’t need a prescription to buy them. These products are not available on the medical card or any other state drug scheme. You can buy vitamin D3 products for babies in pharmacies, some supermarkets and other outlets. It is important that you buy products that are suitable for babies, and contain Vitamin D3 only. What is the cost of Vitamin D3?The cost of vitamin D3 will vary depending on the product. To compare products ask your pharmacist: Depending on the product, you will need to buy more than one bottle in the year.
Do I need to give my baby other vitamins?No. The only vitamin we recommend to give all babies is vitamin D3. Premature infants or infants who are under on-going medical care may require other vitamins or a higher dose of Vitamin D3. Multivitamin products or higher doses of vitamin D3 should only be given to your baby on the advice of your baby’s doctor, nurse or dietitian. Where can I get further information?Ask your pharmacist, doctor, nurse or other healthcare professional for more information. Order a leaflet on www.healthpromotion.ie or download the information leaflet here. Medical terms explained(1)Rickets: soft bones in children, causes severe bone deformities such as bowed legs and spine curves.Osteomalacia: A softening of the bones due to a lack of vitamin D or a problem with the body's ability to break down and use this vitamin. It causes soft bones in adults, causes frequent bone fractures from minor injuries, muscle weakness and bone pain. HSE Policy on Vitamin D Supplementation