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NCT ID: NCT01741324 Completed - Clinical trials for Vitamin D Deficiency

Comparing Different Amounts of Vitamin D Supplementation to Preschool Children Living in Northern and Southern Sweden

Dvisum
Start date: November 2012
Phase: N/A
Study type: Interventional

Vitamin D has a range of biological effects of public health relevance. Vitamin D status is assessed on levels of its metabolite 25-hydroxyvitamin D [25(OH)D], where levels < 50 nmol/L indicate insufficiency. Despite studies indicating that the vitamin D intake among Swedish children are significantly below recommendations, little is known of their vitamin D status. The investigators have recently found inadequate vitamin D status in pre-school children living in northern Sweden, especially in dark-skinned children and during the winter months despite vitamin D intakes meeting the recommendations. Overall, 25% of the light skinned and 40% of the dark skinned children had S-25(OH) D <50 nmol/L (Öhlund I, unpublished data). The aim is to examine which amount of vitamin D is needed to maintain or increase S-25(OH)D to ≥50 nmol/L among 97.5% of the participants regardless of skin color or geographic location (northern or southern Sweden). Furthermore the investigators will examine if vitamin D status affects on health markers as bone density, blood pressure, serum lipids, fatty acids, inflammatory and immunological markers and mental wellbeing. Children aged 5-8 years living either northern (Umeå) or southern Sweden (Malmö) will be recruited to this trial during November-December 2012. They will be randomized to a vitamin D supplement of either 10 or 25 g per day, or in Malmö also placebo to be used for three months. The randomization will be stratified according to skin color (light or dark) according to a method using visual inspection and interviews of parents/guardians. The investigators will use a 2×2×2 factorial design to investigate the effects of two different doses of vitamin D (10 µg and 25 µg) in children with dark and light skin color, living in northern (Umeå) and southern (Malmö), Sweden. In order to achieve a moderate difference between groups (effect size 0.25) 20 children per group are required (power> 87%, alpha = 0.05). With an estimated dropout of 10%, a total of 220 children will be included. At baseline, the participants will undergo blood sampling for S-25(OH)D and other biomarkers, blood pressure and anthropometrical measurements, including bone densitometry and body composition using air displacement pletysmography, and the parents will answer a questionnaire on behavioral and emotional problems in the participating child using the Child Behavior Checklist. These measurements will be repeated at follow-up in February-March 2013.

NCT ID: NCT01741025 Completed - Clinical trials for Sacroiliac Joint Pain

iFuse Implant System® Minimally Invasive Arthrodesis

iMIA
Start date: June 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint

NCT ID: NCT01739101 Completed - Pregnancy Clinical Trials

The Reproductive Life Plan in Midwifery Counseling

Start date: March 2012
Phase: N/A
Study type: Interventional

Many women and men are at risk for sexual transmitted infections and unwanted pregnancies and have unrealistic family planning intentions and insufficient knowledge of health promoting lifestyle prior to conception. Without sufficient support from the health care system this can lead to negative consequences. The aim of our study was to investigate if the usage of the Reproductive Life Plan in midwifery counselling increases women's knowledge of reproduction and particularly knowledge of folic acid intake prior to pregnancy. Secondary aims were to evaluate the influence on women's family planning and to further explore how women experienced the Reproductive Life Plan-based counselling.

NCT ID: NCT01738035 Completed - Clinical trials for Primary IgA Nephropathy

The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease

NEFIGAN
Start date: December 2012
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).

NCT ID: NCT01737801 Completed - Cystic Fibrosis Clinical Trials

Time to Perform Lung Function Test in Cystic Fibrosis

Start date: February 2008
Phase: N/A
Study type: Interventional

Time to perform lung function test after chest physiotherapy in cystic fibrosis. The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital capacity).

NCT ID: NCT01737788 Terminated - Clinical trials for Uterine Cervical Incompetence

Cervical Occlusion for the Prevention of Preterm Birth

Start date: August 2006
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.

NCT ID: NCT01737086 Terminated - Clinical trials for Acute Gastroenteritis

Comparing the Efficacy of Two Oral Rehydration Solutions, With or Without the Probiotic Lactobacillus Reuteri DSM 17938 and Zinc, on the Duration and Severity of Acute Gastroenteritis in 6 - 36 Months Old Children in Out-patient Care

Profat
Start date: December 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Oral rehydration solution (ORS) is recommended for treatment and prevention of dehydration due to acute gastroenteritis in infants and children. Acute diarrhoea leads to zinc depletion in infants, and zinc is recommended by the World Health Organization in the treatment of acute gastroenteritis in infants and children. However, the efficacy of zinc supplementation to children with acute gastroenteritis in more affluent settings is unclear. Selected strains of probiotics, including L. reuteri ATCC 55730, have been shown in several studies to shorten the duration of diarrhoea by about 24 hours, and also to attenuate symptom severity. If probiotics are given within 60 hours from onset of symptoms the duration can be reduced even more. Lactobacillus reuteri (L. reuteri) has been shown to reduce the duration and severity of acute gastroenteritis in children aged 6-36 months. In these studies L. reuteri was proven to have clinical effect on diarrhoea of both bacterial and viral (rotavirus) origin. In humans, L. reuteri strain DSM 17938 has recently been shown to reduce the duration of watery diarrhoea by 1.2 days among 6-36 mo old Italian children with acute gastroenteritis treated in hospital. The present, community-based study aims to assess if an ORS with Lactobacillus reuteri DSM 17938 and zinc can be superior or equivalent to ORS without probiotic and zinc in reducing the duration of acute gastroenteritis in children aged 6-36 months, with no, mild or moderate dehydration when introduced early (within 48 hours) after the start of gastroenteritis associated diarrhoea in an out-patient setting. A prospective, randomized, double blind, controlled study with parallel groups will be performed. Assuming a difference of 25% between groups in the primary outcome of prevalence of diarrhoea 48 hours after start of treatment (80% power, alfa = 5%), and estimating an attrition rate of approximately 15%, the final sample size will be 142 subjects, or 71 subjects in each arm. Parents contacting the health care telephone enquiry agency, the primary care emergency unit, the paediatric emergency unit, all at the Umeå University Hospital or the well-baby care centres (BVC) in Umeå for advice on their children's gastroenteritis will be informed that they may participate in the present study and they will be given contact information to the research nurse for this activity. A home visit by study personnel will then be done for evaluation of eligibility, information, collection of informed consent and delivery of study product. Data collection points will be at the recruitment visit in the patient's home, and by telephone on day 7. If the child still has gastrointestinal symptoms on day 5 it will be referred to the primary health care facility or the outpatient clinic of the Department of Paediatrics, Umeå University Hospital.

NCT ID: NCT01736475 Completed - Hemophilia A Clinical Trials

Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

Start date: January 31, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.

NCT ID: NCT01736384 Completed - Obesity Clinical Trials

Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery

Start date: February 2009
Phase:
Study type: Observational

There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will also study if adenovirus infection can influence the outcome after surgery. In a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. The same tissues will be collected from non-obese controls undergoing gallbladder surgery.

NCT ID: NCT01735955 Completed - Clinical trials for Acute Lymphoblastic Leukemia (ALL)

Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

Start date: March 29, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and were benefiting from the treatment as judged by the investigator