CLINICAL TRIALS PROFILE FOR CALCIUM GLUCONATE

505(b)(2) Clinical Trials for CALCIUM GLUCONATE

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 CALCIUM GLUCONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00058188 ↗	Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation	Terminated	Novartis	Phase 3	2003-03-01	RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
NCT00058188 ↗	Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation	Terminated	Northwestern University	Phase 3	2003-03-01	RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
NCT00004361 ↗	Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects	Completed	Ann & Robert H Lurie Children's Hospital of Chicago		1995-07-01	OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function after induced hypocalcemia. II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same region of chromosome 22q11 as found in patients with DiGeorge anomaly.
NCT00004361 ↗	Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects	Completed	National Center for Research Resources (NCRR)		1995-07-01	OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function after induced hypocalcemia. II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same region of chromosome 22q11 as found in patients with DiGeorge anomaly.

Clinical Trial Conditions for CALCIUM GLUCONATE

Condition Name

Condition Name for CALCIUM GLUCONATE
Intervention	Trials
Osteoporosis	4
Hypocalcemia	2
Prostate Cancer	2
Pain	2

Condition MeSH

Condition MeSH for CALCIUM GLUCONATE
Intervention	Trials
Osteoporosis	4
Breast Neoplasms	3
Ovarian Hyperstimulation Syndrome	3
Peripheral Nervous System Diseases	2

Clinical Trial Locations for CALCIUM GLUCONATE

Trials by Country

+

−

Trials by Country for CALCIUM GLUCONATE
Location	Trials
United States	79
Canada	12
Egypt	4
Mexico	2
Puerto Rico	1

Trials by US State

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−

Trials by US State for CALCIUM GLUCONATE
Location	Trials
Minnesota	4
Illinois	4
New York	3
Wisconsin	3
Georgia	3

Clinical Trial Progress for CALCIUM GLUCONATE

Clinical Trial Phase

Clinical Trial Phase for CALCIUM GLUCONATE
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	10
Phase 2	4

Clinical Trial Status

Clinical Trial Status for CALCIUM GLUCONATE
Clinical Trial Phase	Trials
Completed	18
Recruiting	5
Not yet recruiting	4

Clinical Trial Sponsors for CALCIUM GLUCONATE

Sponsor Name

Sponsor Name for CALCIUM GLUCONATE
Sponsor	Trials
National Cancer Institute (NCI)	6
North Central Cancer Treatment Group	2
Alliance for Clinical Trials in Oncology	2

Sponsor Type

Sponsor Type for CALCIUM GLUCONATE
Sponsor	Trials
Other	40
NIH	7
Industry	2

Calcium Gluconate: Clinical Trials, Market Analysis, and Projections

Introduction to Calcium Gluconate

Calcium gluconate is a mineral supplement derived from the neutralization of gluconic acid with lime or calcium carbonate. It is widely used to treat conditions arising from calcium deficiencies, such as hypocalcemia, tetany, and hypermagnesemia, among others. Here, we will delve into the current clinical trials, market analysis, and future projections for calcium gluconate.

Clinical Trials Update

Current Studies and Applications

One notable clinical trial involving calcium gluconate is the "Empiric Calcium in Massive Transfusion" study conducted by the University of California, Irvine. This Phase 3 research study aims to determine if administering intravenous calcium immediately to patients requiring large volume blood transfusions can decrease transfusion-related complications. The study, though not yet accepting patients, highlights the ongoing interest in the medical applications of calcium gluconate[4].

Market Analysis

Market Size and Growth

The global calcium gluconate market is experiencing significant growth. By 2025, the market size is estimated to reach $976 million, growing at a CAGR of 6.29% during the forecast period of 2020-2025[1].

For the longer term, the market is projected to grow even further. By 2033, the global calcium gluconate market is anticipated to reach around $179.31 billion, growing at a CAGR of 6.15% from 2024 to 2033[5].

Regional Market Dynamics

• Asia-Pacific: This region is the fastest-growing market for calcium gluconate, driven by increasing demand from consumer products and advanced production technologies in countries like China and India[1][2].
• North America: This region holds the largest market share in the calcium gluconate market, with the U.S. market size surpassing $28.14 billion in 2023 and expected to grow to around $51.78 billion by 2033[5].
• Europe: The European market is also significant, with a market size of $26.65 billion in 2023 and projected to expand to around $49.31 billion by 2033[5].

Application Segments

• Pharmaceuticals: This sector holds the largest market share due to the medical benefits of calcium gluconate in treating calcium deficiencies. Pharmaceuticals registered high revenue in 2019 and are poised to continue growing during the forecast period[1][3].
• Food & Beverages: This segment is set to grow with the highest CAGR, driven by the increasing intake of calcium gluconate in various food products. Calcium gluconate serves as a bulking agent, emulsifier, and thickening agent in the food industry[1][3].
• Nutraceuticals and Personal Care: These segments also contribute significantly to the market, with calcium gluconate being a key ingredient in health supplements and skincare products[5].

Form and End-Use Segments

• Forms: The market is segmented into gum, powder, and liquid forms. The powder segment dominates the market due to its ease of use in various foods and beverages. However, the liquid segment is the fastest-growing, particularly in emergency medical situations[5].
• End-Use: The bulking agent segment was the top revenue generator in 2019 and is expected to continue growing, driven by high demand in the pharmaceutical and food industries[1].

Market Drivers

Increasing Demand for Health Supplements

The demand for calcium supplements is increasing globally due to their benefits in treating calcium deficiencies, such as hypocalcemia tetany and hyperparathyroidism-related hypocalcemia. According to the NIH, over 53 million people in the United States suffer from osteoporosis or are at high risk due to low bone mass, further driving the consumption of calcium gluconate[2].

Growing Health Awareness

Health-conscious individuals, particularly in the Asia-Pacific region, are increasingly adopting calcium gluconate as a supplement and food additive. This trend is fueled by the rising awareness of the importance of calcium in maintaining bone health and overall well-being[2].

Market Challenges

Excessive Intake and Side Effects

Excessive intake of calcium gluconate can lead to side effects such as nausea and constipation. These potential health risks, along with regulatory challenges related to product formulation and labeling, can restrain market growth[3].

Regulatory Framework

The market is also influenced by regulatory frameworks. For instance, the approval of GRAS (Generally Recognized as Safe) status for calcium gluconate has expanded its application in the food and beverage industry, but strict regulations on product formulation and labeling must be navigated[3].

Key Players and Market Concentration

The global calcium gluconate market is highly competitive and consolidated, with both regional domestic players and international players. Key players include Akzo Nobel N.V., Spectrum Chemical Manufacturing Corp., Alfa Aesar, Westco Chemicals Inc., and Noah Technologies Corporation. Innovation and product development are major strategic approaches adopted by leading players[2].

Future Projections

Market Growth and Expansion

The calcium gluconate market is expected to continue its growth trajectory, driven by increasing demand from the pharmaceutical, food & beverage, and nutraceutical industries. The Asia-Pacific region will remain a key driver of this growth, with countries like China, India, and Japan playing significant roles[1][2][5].

Technological Innovations

Continuous technological innovations will improve the efficiency and effectiveness of calcium gluconate products. This includes advancements in production technology and the development of new forms and applications, such as liquid calcium gluconate for emergency medical use[5].

Key Takeaways

• The global calcium gluconate market is projected to grow significantly, driven by increasing demand from the pharmaceutical, food & beverage, and nutraceutical industries.
• The Asia-Pacific region is the fastest-growing market, with China and India being key consumption regions.
• The pharmaceutical sector holds the largest market share due to the medical benefits of calcium gluconate.
• The market faces challenges such as potential side effects from excessive intake and regulatory hurdles.
• Technological innovations and increasing health awareness are expected to drive market growth in the future.

FAQs

What is the current market size of the calcium gluconate market?

The global calcium gluconate market size was valued at $98.72 billion in 2023 and is anticipated to reach around $179.31 billion by 2033[5].

Which region is the fastest-growing in the calcium gluconate market?

The Asia-Pacific region is the fastest-growing market for calcium gluconate, driven by increasing demand from consumer products and advanced production technologies[1][2].

What are the primary applications of calcium gluconate?

Calcium gluconate is primarily used in the pharmaceutical, food & beverage, and nutraceutical industries. It serves as a bulking agent, emulsifier, and thickening agent in the food industry and is used to treat calcium deficiencies in the pharmaceutical sector[1][3].

Who are the key players in the calcium gluconate market?

Key players include Akzo Nobel N.V., Spectrum Chemical Manufacturing Corp., Alfa Aesar, Westco Chemicals Inc., and Noah Technologies Corporation[2].

What are the potential side effects of excessive calcium gluconate intake?

Excessive intake of calcium gluconate can lead to side effects such as nausea and constipation[3].

Sources

1. IndustryARC: Calcium Gluconate Market - Forecast(2024 - 2030)[1]
2. Mordor Intelligence: Calcium Gluconate Market Size & Share Analysis[2]
3. Mordor Intelligence: Calcium Gluconate Market Size Summary[3]
4. UC Irvine Clinical Trials: Empiric Calcium in Massive Transfusion[4]
5. Precedence Research: Calcium Gluconate Market Size to Surpass USD 179.31 Bn by 2033[5]