The purpose of the study is to evaluate the impact on quality of life, psychological health, sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with endometriosis, through the administration of self reported questionnaires. Amenorrhea in the first group is caused by balanced assumption of estroprogestins, in the second group is caused by GnRHa-induced hypoestrogenism.

Start Date01 Jun 2021

Sponsor / Collaborator

University of Cagliari

NCT01190683 / CompletedPhase 3IIT

Skeletal Muscle Strength,Bone Mineral Homeostasis and Th1 and Th2 Cytokines Expression in Asian Indians With Chronic Hypovitaminosis D Before and After Oral Cholecalciferol Supplementation

Vitamin D deficiency is widely prevalent in India. Serum 25(OH)D levels are <20 ng /ml in up to 90% of them. Recently, in a randomized control trial, investigators have shown that dual cholecalciferol and calcium supplementation lead to significant improvement in hand grip strength and distance covered during six minutes walk test. Present study is being taken to further understand the functional significance of 25(OH)D in terms of its effect on Skeletal muscle strength including surface electromyography (EMG) in a larger cohort involving approximately 200 subjects. The impact of calcium and vitamin D supplementation would be assessed by supplementing them alone and in combination. Besides, the investigators would also assess impact of above supplementation on Th1/Th2 cytokines expression in the peripheral mononuclear cells.

Start Date01 Aug 2010

Sponsor / Collaborator

Indian Council of Medical Research

NCT01264874 / TerminatedPhase 3IIT

Phase III, Randomized, Double Blind Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients

The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients.

Start Date01 May 2010

Sponsor / Collaborator

Istituto Europeo di Oncologia SRL

100 Clinical Results associated with Colecalciferol/calcium carbonate

100 Translational Medicine associated with Colecalciferol/calcium carbonate

100 Patents (Medical) associated with Colecalciferol/calcium carbonate

Literatures (Medical) associated with Colecalciferol/calcium carbonate

02 Oct 2016·Current Medical Research and OpinionQ4 · MEDICINE

Phase IV randomized preference study in patients eligible for calcium and vitamin D supplementation

Q4 · MEDICINE

Article

Author: Thomasius, Friederike ; Keung Nip, Tsz ; Ivan, Paul

INTRODUCTION/OBJECTIVESPreference for supplement formulation helps determine an individual's adherence to long-term medication and can improve clinical benefit for chronic illnesses such as osteoporosis. This study compared the preference, acceptability and tolerability of a reformulation of Calcichew D3 ¹ 500 mg/400 IU and Calcichew D3 500 mg/800 IU (Takeda UK Ltd, Wobrun Green, UK) with Adcal-D3 ² 500 mg/400 IU (ProStrakan Ltd, Galashiels, UK) and Kalcipos-D 500 mg/800 IU (Meda Pharmaceuticals Ltd, Bishop's Stortford, UK), respectively.METHODThis phase IV, randomized, open-label, two-period, cross-over study was conducted at nine sites in the UK and Germany. Eligible subjects (≥65 years requiring calcium/vitamin D supplementation for prevention/treatment of deficiencies, or ≥18 years requiring supplementation as an adjunct to osteoporosis treatment) were randomly assigned to one of two 2 week treatment sequences - Group 1: Calcichew D3 500/400 then Adcal-D3 500/400 (or vice versa), or Group 2: Calcichew D3 500/800 then Kalcipos-D 500/800 (or vice versa). After each treatment period, patients rated the treatment for acceptability using 100 mm visual analogue scales. After the second treatment period, patients indicated their treatment preference. The primary endpoint, the percentage of patients with a preference for each treatment, was analyzed with a logistic regression model.RESULTSTwo hundred and seventy-six patients were randomly assigned by treatment sequence, 138 to each group. Preference questionnaires among patients who preferred Calcichew or comparator revealed the odds for patients preferring Calcichew 500/400 (77.6%) over Adcal-D3 was 3.46 ([95% CI 2.24, 5.36], p < 0.001) in Group 1, and Calcichew D3 500/800 (63.2%) over Kalcipos-D was 1.72 ([1.19, 2.47], p = 0.004) in Group 2. Adverse events were mostly gastrointestinal and were comparable between groups. The new formulation of Calcichew D3 is acceptable and consistent with its known tolerability profile.CONCLUSIONSIn this short-term 30 day study, patients preferred Calcichew D3 500/400 and Calcichew D3 500/800 over respective comparators. A trend towards better compliance with Calcichew D3 preference observed in Group 1 warrants a longer term study to identify treatment compliance.TRIAL REGISTRATIONClinicaltrials.gov: NCT02457247.

100 Deals associated with Colecalciferol/calcium carbonate

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