Vitamin D treatment in primary hyperparathyroidism: a randomized placebo controlled trial
Rolighed L, Rejnmark L, Sikjaer T, Heickendorff L, Vestergaard P, Mosekilde L, Christiansen P
The Journal of clinical endocrinology and metabolism · 115 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2014-01-14 · J Clin Endocrinol Metab · vol. 99 · número 3 · págs. 1072–1080
- Editorial
- Oxford University Press
- Citado
- 186 citas · más que el 99% de estudios similares · 11.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 45 trabajos
- Acceso
- Acceso abierto (copia en repositorio) · OTHER-OA
- Áreas de investigación
- Parathyroid Disorders and Treatments · Vitamin D Research Studies · Thyroid and Parathyroid Surgery
- Palabras clave
- primary hyperparathyroidism, vitamin D supplementation, vitamin D3, 25-hydroxyvitamin D, parathyroid hormone, parathyroidectomy, bone mineral density, bone resorption, bone turnover markers, trabecular bone score, calcium homeostasis, hungry bone syndrome
- MeSH
- humans, hyperparathyroidism, phosphates, calcium, cholecalciferol, parathyroid hormone, vitamin d, placebos, bone density, adult, aged, middle aged, female, male
7 autores
- Lars Rolighed · autor de correspondencia
- Lars Rejnmark
- Tanja Sikjær
- Lene Heickendorff🇩🇰Aarhus University Hospital
- Peter Vestergaard🇩🇰Aalborg University Hospital
- Leif Mosekilde
- Peer Christiansen
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
Low 25-hydroxyvitamin D levels are common in patients with primary hyperparathyroidism (PHPT) and associated with higher PTH levels and hungry bone syndrome after parathyroidectomy (PTX). However, concerns have been raised about the safety of vitamin D supplementation in PHPT.
Objective
We aimed to assess safety and effects on calcium homeostasis and bone metabolism of supplementation with high doses of vitamin D in PHPT patients.
Design, setting
This was an investigator-initiated double-blind, randomized, placebo-controlled, parallel-group trial from a single center.
Patients
Forty-six PHPT patients were recruited, with a mean age of 58 (range 29-77) years, and 35 (76%) were women.
Interventions
Intervention included daily supplementation with 70 μg (2800 IU) cholecalciferol or identical placebo for 52 weeks. Treatment was administered 26 weeks before PTX and continued for 26 weeks after PTX.
Main outcome measures
PTH, calcium homeostasis, and bone metabolism were evaluated.
Results
Preoperatively, 25-hydroxyvitamin D increased from 50 to 94 nmol/L in the treatment group and decreased from 57 to 52 nmol/L in the placebo group (P < .001). Compared with placebo, vitamin D decreased PTH significantly by 17% before PTX (P = .01), increased lumbar spine bone mineral density by 2.5% (P = .01), and decreased C-terminal β-CrossLaps by 22% (P < .005). The trabecular bone score did not change in response to treatment, but improved after PTX. Postoperatively, PTH remained lower in the cholecalciferol group compared with the placebo group (P = .04). Plasma creatinine and plasma and urinary calcium did not differ between groups.
Conclusions
Daily supplementation with a high vitamin D dose safely improves vitamin D status and decreases PTH in PHPT patients. The vitamin D treatment is accompanied by reduced bone resorption and improved bone mineral density before operation.
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