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Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study.

European journal of endocrinology (2013-09-13)
Sophie Norenstedt, Ylva Pernow, Kerstin Brismar, Maria Sääf, Ayla Ekip, Fredrik Granath, Jan Zedenius, Inga-Lena Nilsson
ABSTRACT

Vitamin D insufficiency may increase the risk for cardio metabolic disturbances in patients with primary hyperparathyroidism (PHPT). To analyze the vitamin D status and indices of the metabolic syndrome in PHPT patients and the effect of vitamin D supplementation after parathyroid adenomectomy (PTX). Double-blinded, randomized clinical trial (ClinicalTrials.gov identifier: NCT00982722) performed at Karolinska University Hospital, Sweden, April 2008 to November 2011. One hundred and fifty consecutive patients with PHPT (119 women) were randomized after PTX, 75 to oral treatment with calcium carbonate 1000 mg daily and 75 to calcium carbonate 1000 mg and cholecalciferol 1600 IU daily over 12 months. Changes in metabolic profile and ambulatory blood pressure (BP) were analyzed. Main outcome measures were changes in metabolic factors, BP, and body composition. The 25-hydroxyvitamin D (25-OH-D)-level was <50 nmol/l in 76% of the patients before PTX. After PTX, glucose, insulin, and IGF1 decreased, while the 25-OH-D and the IGF-binding protein 1 increased and remained unchanged at follow-up after study medication. One year of vitamin D supplementation resulted in lower parathyroid hormone (PTH) (40 (34-52) vs 49 (38-66) ng/l) and higher 25-OH-D (76 (65-93) vs 49 (40-62) nmol/l; P<0.05). Other laboratory parameters were stable compared with after PTX. Systolic BP decreased and total bone mineral content increased in both groups. Except for the lowering of the PTH level, no additive effect of vitamin D supplementation was seen. However, PTX proved effective in reducing insulin resistance.

MATERIALS
Product Number
Brand
Product Description

Cholecalciferol, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Cholecalciferol, analytical standard
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Calcium carbonate, powder, ≤50 μm particle size, 98%
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Calcium carbonate, ACS reagent, chelometric standard, 99.95-100.05% dry basis
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Calcium carbonate, Vetec, reagent grade, 99%
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Calcium carbonate, ACS reagent, ≥99.0%, powder
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Calcium carbonate, ReagentPlus®
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Cholecalciferol (Vitamin D3), Pharmaceutical Secondary Standard; Certified Reference Material