CLINICAL TRIALS PROFILE FOR CALCIUM ACETATE
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505(b)(2) Clinical Trials for CALCIUM ACETATE
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT04039828 ↗ | Zinc Sulfate Acceptability | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | N/A | 2019-09-09 | Introduction: Zinc (Zn) is an essential mineral widely distributed within the human body with metalloproteins, Zinc-binding proteins, etc. It is necessary for signal transduction and also cell growth and proliferation via respective metallo- and zinc-dependent enzymes. Zinc supplementation can significantly reduce diarrheal severity and duration as well as prevents future incidences and reduces use of other medications in diarrhoea. For this reason WHO, UNICEF, USAID and experts worldwide jointly recommended zinc supplementation (10 mg for infants less than 6 months old and 20 mg in 6 - 59 months old) combined with reduced osmolarity ORS for clinical management of acute diarrhoea. But due to strong metallic taste zinc products are less palatable to children even after using masking flavours as recommended by WHO. Several companies have formulated the product since WHO recommendations came but still transient side effects like vomiting and regurgitation remain evident. Despite careful counselling to the caregivers expected adherence rate to 10 days regimen of zinc supplement is yet to be reached. With the aim to increase zinc supplement coverage during acute diarrheal illness, it is necessary to conduct a study to introduce new formulation Zinc tablet which is more palatable, more dispersible and more acceptable. Intervention: Zinc sulfate [Zinc Dispersible Tablet, 20 mg; (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)] Methods: Prospective, open label, interventional study Hypothesis: Improved formulation of Zinc Sulfate will have good acceptability. Study population: Stratum 1: 3 months - <18 months = 175 children Stratum 2: 18 months - 59 months = 175 children Objectives: 1. Primary Objective: Acceptability of the zinc product in the management of childhood diarrhea will be assessed by observing: i) Incidence of vomiting or regurgitation among enrolled children receiving the improvised zinc formulation. ii) The adherence: The number of days (out of the total 10 days) the child took the protocol-prescribed dose of the medicine. The treatment will be considered to have good acceptability if at least 80% of the prescribed treatment is taken by at least 70% of the children over the duration of 10 days, as per WHO guidelines. 2. Secondary objective : To assess palatability Secondary end point evaluation (Palatability): The statistical analysis will comprise the calculation of the percentage of patients out of 350 who found the investigational product to have "very well-tolerated, well-tolerated or tolerated" scores (i.e. any of the upper 3 possible scores). A 95% confidence interval, using the normal approximation of the binomial distribution, will be calculated for the percentage. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for CALCIUM ACETATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00018135 ↗ | Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals | Completed | National Center for Research Resources (NCRR) | N/A | 1969-12-31 | Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet. Some preliminary studies have indicated that the iPTH level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus. If this is true in hemodialysis patients, then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered |
| NCT00114114 ↗ | Dose-Response of Gonadal Steroids and Bone Turnover in Older Men | Completed | AbbVie | N/A | 2004-09-01 | The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men. |
| NCT00114114 ↗ | Dose-Response of Gonadal Steroids and Bone Turnover in Older Men | Completed | AstraZeneca | N/A | 2004-09-01 | The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men. |
| NCT00114114 ↗ | Dose-Response of Gonadal Steroids and Bone Turnover in Older Men | Completed | National Institute on Aging (NIA) | N/A | 2004-09-01 | The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men. |
| NCT00114114 ↗ | Dose-Response of Gonadal Steroids and Bone Turnover in Older Men | Completed | Solvay Pharmaceuticals | N/A | 2004-09-01 | The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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