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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-58bry9
Enrollment
Unknown
Registered
2015-03-09
Start date
2013-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypoparathyroidism, thyroidectomy

Interventions

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"
Drug

Sponsors

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

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.;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 mult

Countries

Brazil

Contacts

Public ContactGláucia;Gláucia Mazeto;Mazeto

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

gmazeto@fmb.unesp.br;gmazeto@fmb.unesp.br+55(14) 3880 1171;55--14--38801171

Outcome results

None listed

Source: REBEC (via WHO ICTRP)