Comparison of Calcium Use in Patients with Lack of Parathyroid Hormone, Taken in Three Different Ways: Fasting, with Water or Orange Juice, and After Breakfast

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-58bry9
• Date of registration: 09/03/2015
• Prospective Registration: No
• Primary sponsor: Faculdade de Medicina de Botucatu - Unesp
• Public title: Comparison of Calcium Use in Patients with Lack of Parathyroid Hormone, Taken in Three Different Ways: Fasting, with Water or Orange Juice, and After Breakfast
• Scientific title: Comparison of the Absorption of Calcium Carbonate in Patients with Definitive Hypoparathyroidism Ingested Three Different Ways: Fasting, with Water or Orange Juice, and After Breakfast
• Date of first enrolment: 01/07/2013
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-58bry9
• Study type: Intervention
• Study design: Clinical trial of treatment, cross-over type, open, with 3 arms.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Gláucia Maria Ferreira da Silva Mazeto
• Affiliation: Faculdade de Medicina de Botucatu - Universidade Estadual Paulista "Júlio de Mesquita Filho" - Unesp

• Name: Gláucia Maria Ferreira da Silva Mazeto
• Affiliation: Faculdade de Medicina de Botucatu - Unesp

Key inclusion & exclusion criteria

Inclusion criteria: Female, regularly followed at the outpatient thyroid neoplasms; carriers after definitive surgical hypoparathyroidism, with persistent symptoms after at least 1 year after completion of total thyroidectomy due to CDT; between 18 and 50 years of age, who had no serious illnesses and who agreed and signed the Informed Consent.
Exclusion criteria: Menopause; neuromotor disorder; sequela of stroke; malabsorptive syndrome; digestive complications of the gastrointestinal tract; decompensated diabetes; severe hypertension; chronic renal failure; liver disease; malnutrition; cancer; manifest hyperthyroidism; severe chronic obstructive pulmonary disease; patients with therapy antirreabsortiva bone, or use of corticosteroids, thiazides, omeprazole and prokinetics; hat are not available to participate in all stages of the study.

Age minimum: 18Y
Age maximum: 50Y
Gender: F

Health Condition(s) or Problem(s) studied

C19.642.482

E04.270.856

hypoparathyroidism, thyroidectomy

Intervention(s)

Twelve female patients, suffering from post-thyroidectomy hypoparathyroidism for differentiated thyroid carcinoma, will be evaluated after the intake of calcium carbonate (CaCO3; 500 mg of elemental calcium)in three different situations, regarding the evolution of calcemia , with 1-week interval between them. In situation "A", CaCO3 is administered fasting with water, the "S" fasting, with orange juice, and "CM" after breakfast, with water. In the first evaluation patients' general information, anthropometric and behavioral will be collected. In each situation, food intake will be assessed by 24-hour recall and blood is collected before and 30, 60, 90, 120, 150, 180, 210, 240, 270 to 300 minutes after ingestion of CaCO3, for dosing calcium.

D01.146.275

Drug

Primary Outcome(s)

Expected outcomes: in the hypoparathyroidism, the ingestion of calcium carbonate (CaCO3) after consumption of food intake compared to fasting with water or orange juice, takes the maintenance of serum calcium (Ca) most suitable.
Method for assessing the expected outcome: performing serum Ca at baseline and every 30 minutes for 5 hours, after ingestion of 500 mg CaCO3 in 3 different ways (with water, orange juice or breakfast).
Parameters used: Statistical comparison of the three curves, the maximum peak and the area under the curve (AUC) of Ca.The intake way that to produce statistically, the curve with the highest concentrations, the highest peak and the largest AUC of Ca would be the most appropriate way of ingestion. There was not a pre-set number or percentage.

Outcome found: in the hypoparathyroidism, calcium carbonate (CaCO3) intake after consumption of food compared to fasting with water or orange juice led to maintain serum calcium (Ca) similar.
Method for assessing the expected outcome: performing serum Ca at baseline and every 30 minutes for 5 hours, after ingestion of 500 mg CaCO3 in 3 different ways (with water, orange juice or breakfast).
Parameters used: Statistical comparison of the three curves, the maximum peak and the area under the curve (AUC) of Ca.The intake way that to produce statistically, the curve with the highest concentrations, the highest peak and the largest AUC of Ca would be the most appropriate way of ingestion. There was not a pre-set number or percentage.The 3 parameters were not statistically different.

Secondary Outcome(s)

Outcome found: in the hypoparathyroidism, calcium carbonate (CaCO3) intake after consumption of food compared to fasting with water or orange juice led to maintain serum phosphorus (P) similar.
Method for assessing the expected outcome: performing serum P at baseline and every 30 minutes for 5 hours, after ingestion of 500 mg CaCO3 in 3 different ways (with water, orange juice or breakfast).
Parameters used: Statistical comparison of the three curves, the maximum peak and the area under the curve (AUC) of P.The intake way that to produce statistically, the curve with the lowest concentrations, the lowest peak and the lower AUC of P would be the most appropriate way of ingestion. There was not a pre-set number or percentage.The 3 parameters were not statistically different.

Expected outcomes: in the hypoparathyroidism,the ingestion of calcium carbonate (CaCO3) after consumption of food intake compared to fasting with water or orange juice, takes the maintenance of product Ca.P most suitable.
Method for assessing the expected outcome: performing serum Ca and P at baseline and every 30 minutes for 5 hours, after ingestion of 500 mg CaCO3 in 3 different ways (with water, orange juice or breakfast), by multiplying both.
Parameters used: Statistical comparison of the three curves, the maximum peak and the area under the curve (AUC) of product Ca.P.The intake way that to produce statistically, the curve with the lowest concentrations, the lowest peak and the smaller AUC of procust Ca.P would be the most appropriate way of ingestion. There was not a pre-set number or percentage.

Outcome found: in the hypoparathyroidism, calcium carbonate (CaCO3) intake after consumption of food compared to fasting with water or orange juice led to maintain serum product Ca.P similar.
Method for assessing the expected outcome: performing serum Ca and P at baseline and every 30 minutes for 5 hours, after ingestion of 500 mg CaCO3 in 3 different ways (with water, orange juice or breakfast), by multiplying both.
Parameters used: Statistical comparison of the three curves, the maximum peak and the area under the curve (AUC) of product Ca.P.The intake way that to produce statistically, the curve with the lowest concentrations, the lowest peak and the smaller AUC of procust Ca.P would be the most appropriate way of ingestion. There was not a pre-set number or percentage.The 3 parameters were not statistically different.

Expected outcomes: in the hypoparathyroidism,the ingestion of calcium carbonate (CaCO3) after consumption of food intake compared to fasting with water or orange juice, takes the maintenance of serum phosphorus (P) most suitable.
Method for assessing the expected outcome: performing serum P at baseline and every 30 minutes for 5 hours, after ingestion of 500 mg CaCO3 in 3 different ways (with water, orange juice or breakfast).
Parameters used: Statistical comparison of the three curves, the maximum peak and the area under the curve (AUC) of P.The intake way that to produce statistically, the curve with the lowest concentrations, the lowest peak and the smaller AUC of P would be the most appropriate way of ingestion. There was not a pre-set number or percentage.

Source(s) of Monetary Support

Faculdade de Medicina de Botucatu - Universidade Estadual Paulista "Júlio de Mesquita Filho" - Unesp

Secondary Sponsor(s)

Faculdade de Medicina de Botucatu - Universidade Estadual Paulista "Júlio de Mesquita Filho" - Unesp