Calcium and Calcitriol Protocols for Hypoparathyroidism
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: CHU de Quebec-Universite Laval
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.
What safety data exists for calcium and calcitriol treatment in hypoparathyroidism?Safety data for calcium carbonate and calcitriol treatment includes the risk of developing milk-alkali syndrome, characterized by hypercalcemia, metabolic alkalosis, and renal impairment. This syndrome can occur with excessive intake of calcium carbonate, as seen in cases involving antacids like Tums. Patients with conditions such as renal failure or those using thiazide diuretics are at higher risk and should be monitored for alkalosis and hypercalcemia. While calcium carbonate is generally safe at recommended doses, exceeding 2,000 mg of calcium daily without medical advice can lead to mineral deficiencies and other complications. It is important to manage calcium intake carefully and monitor for any adverse effects.35789
What data supports the idea that Calcium and Calcitriol Protocols for Hypoparathyroidism is an effective treatment?The available research shows that conventional treatment for hypoparathyroidism includes oral calcium, often in the form of calcium carbonate, and vitamin D supplements. Calcium carbonate is preferred because it contains a high percentage of elemental calcium, which is important for managing the condition. While the research does not directly compare this treatment to others for hypoparathyroidism, it highlights the importance of calcium carbonate in maintaining necessary calcium levels in the body. Additionally, the research mentions that calcium citrate is more bioavailable than calcium carbonate, suggesting it might be more effective in certain situations, although it is not the primary choice for hypoparathyroidism.146911
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is the drug Calcium Carbonate and Calcitriol a promising treatment for hypoparathyroidism?Yes, Calcium Carbonate and Calcitriol is a promising treatment for hypoparathyroidism. It helps control low calcium levels in the blood, which is a key issue in this condition. Calcium Carbonate is effective because it provides a high amount of calcium, and Calcitriol, a form of vitamin D, helps the body absorb calcium better. Together, they work well to manage the symptoms of hypoparathyroidism.1261011
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
I need surgery to remove lymph nodes in my neck.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Group I: PTH based repletion groupExperimental Treatment1 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 groupExperimental Treatment1 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 United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Calcium carbonate for:
- Symptomatic relief of heartburn, acid indigestion, and sour stomach
- Calcium supplementation
- Post-thyroidectomy hypocalcemia management
🇪🇺 Approved in European Union as Calcium carbonate for:
- Symptomatic relief of heartburn, acid indigestion, and sour stomach
- Calcium supplementation
- Post-thyroidectomy hypocalcemia management
🇨🇦 Approved in Canada as Calcium carbonate for:
- Symptomatic relief of heartburn, acid indigestion, and sour stomach
- Calcium supplementation
- Post-thyroidectomy hypocalcemia management
Find a clinic near you
Research locations nearbySelect from list below to view details:
CHU de QuebecQuébec, Canada
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Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
References
Calcium carbonate 1250 mg/1260 mg: an effective phosphate binder. [2017]Calcium carbonate is currently the first choice phosphate binder in renal failure. In the UK its most widely prescribed formulation is a combination of calcium carbonate 420 mg and glycine 180 mg (Titralac 3M Riker). In order to achieve adequate reduction in the serum phosphate level, up to 12 of these tablets may be required daily. In a group of seven patients, we have compared Titralac with two alternative preparations containing calcium carbonate 1250 mg (Calcium-500 Macarthy's Medical Ltd) and calcium carbonate 1260 mg (Calcichew Shire Pharmaceuticals Ltd). Given at a third of the daily number of Titralac tablets, both these newer preparations were effective phosphate binders and produced no statistically significant change in serum calcium and phosphate. The important advantage of such a reduced tablet load is improved patient compliance with phosphate binder therapy. Calcium-500 is also a cost-effective treatment slightly reducing the cost when compared with combined calcium carbonate 420 mg and glycine 180 mg.
Oral calcium chloride in hypoparathyroidism refractory to massive doses of calcium carbonate and vitamin D. [2019]Surgically induced hypoparathyroidism often responds satisfactorily to intravenous Ca administration, oral CaCO3 and vitamin D2. A 17-year-old girl developed hypoparathyroidism following partial thyroidectomy for thyrotoxicosis. Hypocalcemia was refractory to treatment with massive doses of vitamin D2, up to 150,000 U, 3-6 gm of oral Ca as CaCO3 and 2 micrograms of 1,25-dihydroxycholecalciferol per day. Intravenous Ca gluconate (360 mg of elemental Ca/d, in divided doses) was needed to correct tetany. After 25 days of unsuccessful therapy, oral administration of 30 ml of a 10% solution of CaCl2 (1.09 gm of elemental Ca) was followed by normalization of serum Ca (8.9 mg/dl) within 7 hours. This dose was repeated every 8 hours for 6 days and oral CaCO3 and IV Ca gluconate were discontinued. Serum Ca remained within normal range but hyperchloremic acidosis developed. This was corrected by providing, in addition to vitamin D, 2 g/d of Ca supplementation, 1 gm in the form of 10% CaCl2 solution and 1 gm as CaCO3 in two doses given simultaneously. During 12 months of observation, serum Ca, P and Cl have been consistently within normal limits. This patient was found to have achlorhydria, unresponsive to normalization of thyroid function and serum Ca. These findings indicate that refractoriness to oral CaCO3 and vitamin D may be caused by achlorhydria. Oral administration of CaCl2 solution can promptly correct this defect. Monitoring of serum Cl and CO2 is needed to avoid hyperchloremic acidosis.
Milk-alkali syndrome in patients treated with calcium carbonate after cardiac transplantation. [2023]Heart and heart-lung transplant recipients at Stanford (Calif) University Medical Center were routinely prescribed long-term calcium carbonate antacid therapy to aid in the prevention of peptic ulcer disease and osteoporosis associated with glucocorticoid immunosuppressive therapy. Patients consumed 4 to more than 10 g/d of elemental calcium. Since calcium carbonate also provides the essential ingredients for the development of the milk-alkali syndrome, the laboratory flow sheets of 297 heart and heart-lung transplant recipients were reviewed to examine the incidence of hypercalcemia. Sixty-five patients developed significant hypercalcemia after transplantation. Thirty-one patients were alkalotic at the time of hypercalcemia; 37 had impairment in renal function. It is likely that most of these patients had the milk-alkali syndrome. While most patients became eucalcemic by discontinuing calcium carbonate therapy, intravenous hydration and forced diuresis were used to treat severe cases. It is possible that the incidence of the milk-alkali syndrome will increase with the current popularity of prescribing calcium carbonate for the prevention and treatment of osteoporosis.
Absence of rebound effect with calcium carbonate. [2018]This was an open, randomised balance cross-over study in 12 healthy male volunteers. The antacid activity of calcium carbonate plus magnesium carbonate (Rennie and hydrotalcite (Talcid), given in the recommended dose of 2 tablets 4 times daily, were compared using 24 h intragastric measurement of pH. The volunteers received 2 tablets of calcium carbonate plus magnesium carbonate or hydrotalcite according to a randomised order 1 h after each meal and at bedtime. Results showed that both treatments have similar antacid efficacy and a similar duration of action of about one hour. There was no evidence of acid 'rebound' following either treatment during the second and third hours following the administration of antacid.
Calcium supplementation. [2023]Calcium is necessary for the prevention and treatment of diseases such as osteoporosis, hypertension, and, possibly, colon cancer. Supplementation is useful when dietary calcium intake is low, as is the current situation in North America. There are many factors to consider before recommending any one form of supplement. A consideration for calcium carbonate tablets is whether the tablet disintegrates and whether or not a lack of food or acid in the stomach will hinder utilization. Other forms of calcium, particularly the chelated calcium salts, are better absorbed in fasting achlorhydric subjects but have less calcium per gram of supplement. Interaction of calcium with other mineral nutrients and the presence of contaminating metals has focused attention on safety. Based on present evidence, chelated calcium and refined calcium carbonate tablets (including those labeled as antacids) may be safely and effectively ingested by most people at doses generally recommended for treatment or prevention of osteoporosis. One should not exceed 2,000 mg of calcium, except at the advice of their health care provider, as inadvertent mineral deficiencies may arise. Persons at risk for developing milk-alkali syndrome, such as thiazide users and persons with renal failure, should be identified and monitored for alkalosis and hypercalcemia when using calcium supplements.
Pharmacokinetic and pharmacodynamic comparison of two calcium supplements in postmenopausal women. [2013]This randomized crossover study compared the single-dose bioavailability and effects on parathyroid function of two commercially formulated calcium supplements containing 500 mg of elemental calcium. Twenty-five postmenopausal women underwent three phases of study wherein they each took a single dose of calcium citrate with a standard breakfast (as Citracal 250 mg + D), calcium carbonate (as Os-Cal 500 mg + D), or placebo at 8 a.m. Blood samples were drawn at baseline and hourly for 4 or 6 hours after each dose. Fasting and postload urine samples were also collected. Compared with calcium carbonate, calcium citrate provided a 46% greater peak-basal variation and 94% higher change in area under the curve for serum calcium and a 41% greater increment in urinary calcium. Moreover, the decrement in serum parathyroid hormone concentration from baseline was greater after calcium citrate. In conclusion, calcium citrate is more bioavailable than calcium carbonate when given with a meal.
Effects of Aluminum/Magnesium Hydroxide and Calcium Carbonate on Esophageal and Gastric pH in Subjects with Heartburn. [2019]This single-blind crossover trial compared the effects of single oral doses of two antacids on esophageal and gastric pH in subjects with heartburn. Gastric and esophageal pH were assessed in 83 subjects from 1 h before to 4 h after a refluxogenic meal. Subjects received two chewable tablets of a high-potency aluminum/magnesium hydroxide [Al(OH)3/Mg(OH)2] formulation (Mylanta Double-Strength(TM)) or a calcium carbonate [CaCO3] formulation (Tums E-X(TM)), or placebo 1 h after the meal. Both antacid formulations significantly increased esophageal pH, as compared with placebo. Onset of action was faster with the Al(OH)3/Mg(OH)2 formulation than with the CaCO3 in 41 subjects, slower in 13 subjects, and identical in 29 subjects. Area under the esophageal pH--time curves after dosing were significantly greater for Al(OH)3/Mg(OH)2 than for CaCO3 (p
[Calcium suppletion for patients who use gastric acid inhibitors: calcium citrate or calcium carbonate?]. [2013]Various calcium supplements are available for patients who have an indication for calcium suppletion. American guidelines and UpToDate recommend prescribing calcium citrate to patients who use antacids The rationale for this advice is that water-insoluble calcium carbonate needs acid for adequate absorption. No convincing scientific evidence supporting the advice to prescribe calcium citrate instead of calcium carbonate to patients who also take antacids is available, and therefore deserves further investigation. On the contrary, the fact that calcium carbonate does not need acid in order to be absorbed, has also not been proven. In clinical practise, it appears important that calcium is taken with meals in order to improve its absorption.
No more milk in milk-alkali syndrome: a case report. [2021]This is a case of Milk-AlKali syndrome in a patient who presented with the classical triad of hypercalcemia, metabolic alkalosis and renal impairment. The source of calcium was over-the-counter calcium-containing antacid (Tums®). Milk-alkali syndrome was first recognized secondary to treatment of peptic ulcer disease with milk and absorbable alkali. Its incidence fell after the introduction of H2-blocker and proton pump inhibitor. However, it is one of the leading causes of hypercalcemia nowadays because of the wide availability, increased marketing and use of calcium carbonate especially in osteoporosis prevention and treatment. The demographics of milk-alkali syndrome have changed compared to when it was initially described. The presentation could be acute, subacute or chronic. Early diagnosis, discounting calcium supplement and intravenous hydration are the mainstay of MAS management.
Hypoparathyroidism: what is the best calcium carbonate supplementation intake form? [2022]In hypoparathyroidism, calcium supplementation using calcium carbonate is necessary for the hypocalcemia control. The best calcium carbonate intake form is unknown, be it associated with feeding, juice or in fasting.
Conventional Treatment of Hypoparathyroidism. [2019]Conventional therapy of hypoparathyroidism consists of oral calcium and either activated vitamin D or vitamin D supplements at varying doses. Although adjusting dosing of calcium and/or activated vitamin D or vitamin D itself, the serum calcium should be obtained weekly or monthly depending on the clinical situation. Calcium supplementation in hypoparathyroidism usually consists of calcium carbonate because it is 40% elemental calcium by weight. However, calcium citrate (21% elemental calcium) is indicated for patients with achlorhydria and proton pump inhibitor therapy. Many clinicians prefer to uptitrate the activated form of vitamin D to reduce the amount of calcium supplementation.