CLINICAL TRIALS PROFILE FOR AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

505(b)(2) Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

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.

All Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00118482 ↗	Clinical Trial for the Prevention of Vasovagal Syncope	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	2005-05-01	The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo. Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.
NCT00118482 ↗	Clinical Trial for the Prevention of Vasovagal Syncope	Completed	University of Calgary	Phase 4	2005-05-01	The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo. Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.
NCT00212043 ↗	Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma	Completed	Eli Lilly and Company	Phase 2	2000-07-01	Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT00212043 ↗	Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma	Completed	National University Hospital, Singapore	Phase 2	2000-07-01	Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	Thrasher Research Fund	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	World Bank	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.

Clinical Trial Conditions for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Condition Name

Condition Name for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Intervention	Trials
Diabetes	2
Low Back Pain	1
Renal Stones	1
Acute Diarrhea	1

Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Intervention	Trials
Diarrhea	2
Ketosis	2
Diabetic Ketoacidosis	2
Dentin Sensitivity	1

Clinical Trial Locations for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Trials by Country

Trials by Country for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Location	Trials
United States	12
Canada	10
Bangladesh	3
Thailand	1
Brazil	1

Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Location	Trials
Virginia	2
Massachusetts	2
California	1
Tennessee	1
New York	1

Clinical Trial Progress for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Clinical Trial Phase	Trials
Completed	10
Recruiting	3
Unknown status	2

Clinical Trial Sponsors for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Sponsor Name

Sponsor Name for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Sponsor	Trials
International Centre for Diarrhoeal Disease Research, Bangladesh	3
OncoGenex Technologies	1
Alphacait, LLC	1

Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Sponsor	Trials
Other	26
Industry	5
NIH	1

Clinical Trials, Market Analysis, and Projections for Amino Acids, Magnesium Chloride, Potassium Acetate, Potassium Chloride, and Sodium Chloride

Introduction to the Components

The combination of amino acids, magnesium chloride, potassium acetate, potassium chloride, and sodium chloride is often used in various medical and nutritional applications. Here’s a breakdown of each component and their roles:

• Amino Acids: Essential for protein synthesis, hormone production, and numerous biological processes. They are crucial in both human and animal nutrition[5].
• Magnesium Chloride: Used in pharmaceuticals, de-icing, and as a supplement to meet magnesium requirements in the human body[2].
• Potassium Acetate: Utilized in pharmaceuticals, food, and industrial applications, known for its role in maintaining electrolyte balance[3].
• Potassium Chloride: Commonly used in medical treatments to manage electrolyte imbalances and in food preservation[4].
• Sodium Chloride: Widely used in medical treatments, food preservation, and various industrial applications[4].

Clinical Trials Update

The combination of these components, particularly in formulations like amino acids/dextrose/magnesium chloride/potassium acetate/potassium chloride/potassium phosphate, dibasic/sodium chloride, has been subject to various clinical trials and medical evaluations.

• R&D Status and Clinical Results: These formulations have been evaluated for their efficacy in treating nutrition disorders and other metabolic conditions. However, some formulations have been withdrawn from further development. For instance, a formulation by Hospira, Inc. was approved in the US in 1988 but has since been withdrawn[4].
• Therapeutic Areas: These components are often used in endocrinology and metabolic disease treatments, highlighting their importance in managing nutritional and electrolyte imbalances[4].

Market Analysis

Each of these components has a significant market presence, driven by their diverse applications.

Amino Acids Market

• The global amino acids market was valued at USD 31.23 billion in 2024 and is projected to reach USD 63.95 billion by 2033, growing at a CAGR of 8.5% during the forecast period (2025-2033). The market is driven by extensive applications in the food, animal feed, and pharmaceutical sectors[5].

Magnesium Chloride Market

• The global magnesium chloride market is expected to rise at a CAGR of 6.3% and reach US$ 3.05 billion by 2034. The market is driven by increasing demand from the pharmaceutical and de-icing sectors. The United States and China are key markets, with China expected to occupy a significant share of the East Asian market by 2034[2].

Potassium Acetate Market

• The global potassium acetate market was valued at USD 201.87 million in 2022 and is projected to reach USD 290.66 million by 2030, growing at a CAGR of 4.66% during the forecast period. The market is driven by applications in pharmaceuticals, food, and industrial sectors[3].

Potassium Chloride and Sodium Chloride Markets

• While specific market projections for potassium chloride and sodium chloride are not detailed in the sources, these components are widely used and have stable demand across various industries, including medical treatments and food preservation.

Market Projections

Amino Acids

• The amino acids market is expected to see significant growth, driven by increasing health awareness and the use of amino acids in dietary supplements and functional foods. The Asia-Pacific region, particularly China, is a key driver due to its robust animal feed industry[5].

Magnesium Chloride

• The magnesium chloride market will continue to grow, driven by its use in pharmaceuticals and de-icing. China and the United States will remain key markets, with China expected to account for a significant share of the East Asian market by 2034[2].

Potassium Acetate

• The potassium acetate market is projected to grow at a CAGR of 4.66% from 2023 to 2030, driven by its applications in pharmaceuticals, food, and industrial sectors[3].

Key Factors Driving Market Growth

• Increasing Health Awareness: Growing health awareness is propelling the use of amino acids in dietary supplements and functional foods, reflecting a shift toward preventative health measures[5].
• Industrialization and Technological Advancements: Advancements in fermentation technology and synthetic biology are broadening the scope of potential applications for these components[5].
• Regulatory Frameworks: Evolving regulatory frameworks are shaping market dynamics, particularly in the pharmaceutical and food sectors[5].
• Geographical Demand: The Asia-Pacific region, especially China, is pivotal in both production and consumption, driven by a robust animal feed industry and easy availability of raw materials[2][5].

Conclusion

The market for amino acids, magnesium chloride, potassium acetate, potassium chloride, and sodium chloride is driven by their diverse and critical applications across various industries. As health awareness increases and technological advancements continue, these markets are expected to see significant growth.

Key Takeaways

• The global amino acids market is projected to reach USD 63.95 billion by 2033.
• Magnesium chloride market is expected to reach US$ 3.05 billion by 2034.
• Potassium acetate market is projected to reach USD 290.66 million by 2030.
• These components are crucial in pharmaceuticals, dietary supplements, and therapeutic treatments.
• Growing health awareness and technological advancements are key drivers of market growth.

FAQs

Q: What are the primary applications of amino acids in the market? A: Amino acids are essential in pharmaceutical formulations, dietary supplements, and therapeutic treatments, serving as building blocks for proteins and participating in numerous biological processes[5].

Q: Why is magnesium chloride extensively used in the pharmaceutical sector? A: Magnesium chloride is used in medical drug production and as a supplement to meet the magnesium requirement of the human body, playing a significant role in various physiological procedures[2].

Q: What drives the demand for potassium acetate in the market? A: The demand for potassium acetate is driven by its applications in pharmaceuticals, food, and industrial sectors, as well as its role in maintaining electrolyte balance[3].

Q: How does the Asia-Pacific region influence the amino acids market? A: The Asia-Pacific region, particularly China, is pivotal in both production and consumption, driven by a robust animal feed industry and growing health awareness[5].

Q: What are the key factors driving the growth of the magnesium chloride market? A: The growth of the magnesium chloride market is driven by increasing demand from the pharmaceutical and de-icing sectors, as well as the easy availability of raw materials and production facilities in countries like China[2].

Sources

1. IndustryARC - Feed Amino Acids Market - Forecast(2024 - 2030)
2. Fact.MR - Magnesium Chloride Market Size, Share & Growth 2034
3. Zion Market Research - Global Potassium Acetate Market Size, Share, Analysis and Forecast
4. Synapse - Amino Acids/Dextrose/Magnesium chloride/Potassium acetate/Potassium chloride/Potassium phosphate, dibasic/Sodium chloride
5. StraitsResearch - Amino Acids Market Size, Share | Forecast Report 2033