Calcium and Calcitriol Protocols for Hypoparathyroidism

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: CHU de Quebec-Universite Laval

Disqualifiers: Neck dissection, Intellectual deficit, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing two ways to give calcium and vitamin D to patients with low hormone levels after thyroid surgery. One method gives supplements to everyone right away, while the other gives them only if hormone levels drop significantly. The goal is to see which method improves quality of life more.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Calcium Carbonate and Calcitriol for treating hypoparathyroidism?

Calcium carbonate is commonly used in hypoparathyroidism treatment because it provides a high amount of elemental calcium, which is essential for managing the condition. Additionally, conventional therapy for hypoparathyroidism often includes calcium and activated vitamin D, like calcitriol, to maintain proper calcium levels in the blood. ^{1 2 3 4 5}

Is calcium carbonate and calcitriol treatment safe for humans?

Calcium carbonate and calcitriol are generally safe for most people when used as directed, but excessive intake can lead to milk-alkali syndrome, which causes high calcium levels, kidney problems, and metabolic alkalosis (a condition where the body becomes too alkaline). People with certain conditions, like kidney issues or those taking specific medications, should be monitored for these risks. ^{4 6 7 8 9}

How is the drug for hypoparathyroidism different from other treatments?

This treatment for hypoparathyroidism is unique because it combines calcium carbonate and calcitriol (an active form of vitamin D) with a focus on PTH (parathyroid hormone) based calcium repletion, which may help in better managing calcium levels compared to conventional treatments that rely solely on calcium and vitamin D supplements. ^{1 2 3 10 11}

Research Team

Eligibility Criteria

This trial is for individuals who have undergone a total thyroidectomy or completion hemithyroidectomy and are dealing with hypoparathyroidism. Participants must be able to complete questionnaires in English or French, without severe psychiatric disorders, intellectual deficits, illiteracy, or the need for neck dissection.

Inclusion Criteria

I have had my entire thyroid or half of it surgically removed.

Exclusion Criteria

Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)

I need surgery to remove lymph nodes in my neck.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive calcium carbonate and calcitriol post-operatively, with monitoring of PTH levels to determine treatment protocol

4 weeks

2 visits (in-person) at 1 week and 4 weeks post-op

Follow-up

Participants are monitored for quality of life, symptoms of hypocalcemia, and adverse effects of treatment

4 weeks

2 visits (in-person) at 1 week and 4 weeks post-op

Treatment Details

Interventions

• Empiric use of Calcium Carbonate and Calcitriol (Other)
• PTH based Calcium Carbonate and Calcitriol repletion (Other)

Trial Overview The study compares two treatment protocols for managing low parathyroid hormone levels after thyroid surgery: one uses PTH levels to determine calcium and vitamin D dosing (Calcitriol), while the other uses a fixed dose regardless of PTH levels.

Participant Groups

Group I: PTH based repletion group Experimental Treatment 1 Intervention

Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.

Group II: Empiric calcium and calcitriol repletion group Experimental Treatment 1 Intervention

All patients in this group will receive post-operative calcium carbonate and calcitriol.

Empiric use of Calcium Carbonate and Calcitriol is already approved in Canada for the following indications:

Approved in Canada as Calcium carbonate for:

• Symptomatic relief of heartburn, acid indigestion, and sour stomach
• Calcium supplementation
• Post-thyroidectomy hypocalcemia management

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Findings from Research

In a study involving 25 postmenopausal women, calcium citrate was found to be 46% more effective than calcium carbonate in raising serum calcium levels after a meal, indicating higher bioavailability.

Calcium citrate also led to a greater reduction in parathyroid hormone levels compared to calcium carbonate, suggesting it may be more effective in supporting bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and pharmacodynamic comparison of two calcium supplements in postmenopausal women. Heller, HJ., Greer, LG., Haynes, SD., et al.[2013]

Conventional treatment for hypoparathyroidism involves oral calcium and vitamin D supplements, with calcium carbonate being the most common choice due to its higher elemental calcium content.

Calcium citrate is recommended for patients with low stomach acid, and clinicians often increase the dose of activated vitamin D to minimize the need for calcium supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional Treatment of Hypoparathyroidism. Babey, M., Brandi, ML., Shoback, D.[2019]

In a study involving seven patients, two alternative calcium carbonate preparations (Calcium-500 and Calcichew) were found to be effective phosphate binders at a significantly lower dosage compared to the commonly prescribed Titralac, which requires up to 12 tablets daily.

Both alternative preparations did not cause significant changes in serum calcium and phosphate levels, suggesting they are safe options that can improve patient compliance and reduce treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium carbonate 1250 mg/1260 mg: an effective phosphate binder. Taylor, JE., Henderson, IS., Stewart, WK., et al.[2017]

In a study involving 12 healthy male volunteers, both calcium carbonate plus magnesium carbonate and hydrotalcite were found to have similar antacid efficacy, effectively neutralizing stomach acid for about one hour after administration.

Neither treatment caused acid 'rebound' effects, meaning that there was no increase in stomach acidity after the antacids wore off, indicating a safe profile for both medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absence of rebound effect with calcium carbonate. Simoneau, G.[2018]

In a study involving 83 subjects, the aluminum/magnesium hydroxide antacid (Mylanta Double-Strength) was found to be more effective than calcium carbonate (Tums E-X) in increasing esophageal pH, with a faster onset and longer duration of action (82 minutes vs. 60 minutes).

Only the aluminum/magnesium hydroxide formulation significantly increased gastric pH compared to placebo, while calcium carbonate often resulted in an 'acid rebound' effect, indicating that the primary action of both antacids is in the lower esophagus for heartburn relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aluminum/Magnesium Hydroxide and Calcium Carbonate on Esophageal and Gastric pH in Subjects with Heartburn. Decktor, DL., Robinson, M., Maton, PN., et al.[2019]

In a review of 297 heart and heart-lung transplant recipients, 65 patients developed significant hypercalcemia, likely due to the long-term use of calcium carbonate antacid therapy prescribed to prevent peptic ulcer disease and osteoporosis.

Most patients with hypercalcemia returned to normal calcium levels after stopping calcium carbonate, but severe cases required intravenous hydration and diuretics, highlighting the need for careful monitoring of calcium levels in patients on this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Milk-alkali syndrome in patients treated with calcium carbonate after cardiac transplantation. Kapsner, P., Langsdorf, L., Marcus, R., et al.[2023]

Current American guidelines recommend calcium citrate for patients using antacids, but there is no strong scientific evidence to support this preference over calcium carbonate.

Calcium absorption may be improved when taken with meals, regardless of whether calcium citrate or calcium carbonate is used, indicating that meal timing could be an important factor in calcium supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Calcium suppletion for patients who use gastric acid inhibitors: calcium citrate or calcium carbonate?]. de Jonge, HJ., Gans, RO., Huls, G.[2013]

Calcium supplementation is important for preventing and treating conditions like osteoporosis and hypertension, especially in North America where dietary intake is often low.

Chelated calcium and refined calcium carbonate supplements are generally safe and effective for most people, but it's crucial not to exceed 2,000 mg of calcium without medical advice due to potential risks like mineral deficiencies and milk-alkali syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium supplementation. Whiting, SJ., Wood, R., Kim, K.[2023]

In a study involving 12 women with hypoparathyroidism after total thyroidectomy, calcium carbonate intake in different forms (fasting, with water, orange juice, and breakfast) resulted in similar serum levels of calcium and phosphorus, indicating that the form of intake may not significantly affect absorption.

The maximum serum levels of calcium and phosphorus were comparable across all intake methods, suggesting that patients can take calcium carbonate with or without food or juice without impacting its effectiveness in managing hypocalcemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoparathyroidism: what is the best calcium carbonate supplementation intake form? Gollino, L., Biagioni, MFG., Sabatini, NR., et al.[2022]

A 17-year-old girl with surgically induced hypoparathyroidism showed severe hypocalcemia that did not respond to high doses of vitamin D and oral calcium, requiring intravenous calcium gluconate for tetany correction.

Oral administration of a 10% calcium chloride solution effectively normalized serum calcium levels within hours, suggesting that achlorhydria may hinder the absorption of oral calcium supplements, and highlighting the need for careful monitoring to prevent hyperchloremic acidosis during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral calcium chloride in hypoparathyroidism refractory to massive doses of calcium carbonate and vitamin D. Komindr, S., Schmidt, LW., Palmieri, GM.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and pharmacodynamic comparison of two calcium supplements in postmenopausal women. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Conventional Treatment of Hypoparathyroidism. [2019]

3. Scotland pubmed.ncbi.nlm.nih.gov

Calcium carbonate 1250 mg/1260 mg: an effective phosphate binder. [2017]

4. Oman pubmed.ncbi.nlm.nih.gov

No more milk in milk-alkali syndrome: a case report. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Absence of rebound effect with calcium carbonate. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of Aluminum/Magnesium Hydroxide and Calcium Carbonate on Esophageal and Gastric pH in Subjects with Heartburn. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Milk-alkali syndrome in patients treated with calcium carbonate after cardiac transplantation. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Calcium suppletion for patients who use gastric acid inhibitors: calcium citrate or calcium carbonate?]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Calcium supplementation. [2023]

10. Brazil pubmed.ncbi.nlm.nih.gov

Hypoparathyroidism: what is the best calcium carbonate supplementation intake form? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Oral calcium chloride in hypoparathyroidism refractory to massive doses of calcium carbonate and vitamin D. [2019]