Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-05-31

Brief Summary

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To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.

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Detailed Description

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In primary hyperparathyroidism, chronic-elevated PTH levels seem to stimulate the renin-angiotensin-aldosterone system (RAAS) which may explain the increased risk of cardiovascular disease. In addition to increased PTH levels, vitamin D has been shown to inhibit the RAAS. However, a possible physiologic interaction needs further investigation.

The purpose of the study is to investigate changes in the RAAS in otherwise healthy postmenopausal women with secondary hyperparathyroidism due to vitamin D deficiency when p-PTH is normalized.

Furthermore, we will evaluate whether an angiotensin 2 receptor blocker can lower PTH in patients with secondary hyperparathyroidism.

Conditions

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Osteoporosis Vitamin D Deficiency Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cholecalciferol

Cholecalciferol 70 mcg/day for 12 weeks Placebo Valsartan daily for 2 weeks

Group Type PLACEBO_COMPARATOR

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

12 weeks of daily cholecalciferol treatment, 70 microgram per day

Valsartan

Placebo cholecalciferol/day for 12 weeks Valsartan 80 mg/day for 2 weeks

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

2 weeks of Valsartan 80 mg per day

Placebo

Placebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo Valsartan

Intervention Type DRUG

2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.

Placebo cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.

Cholecalciferol and Valsartan

Cholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks

Group Type ACTIVE_COMPARATOR

Valsartan

Intervention Type DRUG

2 weeks of Valsartan 80 mg per day

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

12 weeks of daily cholecalciferol treatment, 70 microgram per day

Interventions

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Valsartan

2 weeks of Valsartan 80 mg per day

Intervention Type DRUG

Placebo Valsartan

2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.

Intervention Type DRUG

Cholecalciferol

12 weeks of daily cholecalciferol treatment, 70 microgram per day

Intervention Type DIETARY_SUPPLEMENT

Placebo cholecalciferol

12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitamin D3 Placebo D3

Eligibility Criteria

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Inclusion Criteria

* Secondary hyperparathyroidism due to Vitamin D deficiency

Exclusion Criteria

* Cardiovascular disease
* Renal failure
* Liver failure
* Treatment with antihypertensive medication or diuretics
* Treatment with lithium, NSAID or glucocorticoids
* Calcium supplement more than 500 mg per day or Vitamin D supplement more than 25 microgram per day
* Medical treatment for osteoporosis
* Systolic blood pressure below 120 mmHg
* Hypercalcaemia (more than 1,33mmol/L)
* Use of solarium or planned trip to countries, that might increase the endogenous vitamin D synthesis
* Allergic reaction to ACEi or ARBs.

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No