Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

NCT02572960 | Completed Phase 4 DMC

• 1 other identifier: 2014-LSB
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis; Vitamin D Deficiency; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Aldosterone, before and after 12 weeks of daily cholecalciferol treatment

  Change from baseline p-aldosterone at 12 weeks

Secondary Outcomes (15)

• Parathyroid hormone, before and after, daily ARB administrations

  Change from baseline p-PTH at 2 weeks

• Arterial stiffness

  Change from baseline arterial stiffness at 12 weeks

• 24 hours arterial stiffness as measured by tonometry

  Change from baseline arterial stiffness PWV at 12 weeks

• 24 hours blood pressure measured by tonometry

  Change from baseline systolic pressure at 12 weeks

• Balance as measured by stadiometer (Meitur Ltd)

  Change from postural balance at 12 weeks

Study Arms (4)

Cholecalciferol

PLACEBO COMPARATOR

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

Dietary Supplement: Cholecalciferol

Valsartan

ACTIVE COMPARATOR

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

Drug: Valsartan

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Valsartan; Dietary Supplement: Placebo cholecalciferol

Cholecalciferol and Valsartan

ACTIVE COMPARATOR

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

Drug: Valsartan; Dietary Supplement: Cholecalciferol

Interventions

Valsartan DRUG

2 weeks of Valsartan 80 mg per day

Cholecalciferol and Valsartan; Valsartan

Placebo Valsartan 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 DIETARY_SUPPLEMENT

12 weeks of daily cholecalciferol treatment, 70 microgram per day

Also known as: Vitamin D3

Cholecalciferol; Cholecalciferol and Valsartan

Placebo cholecalciferol DIETARY_SUPPLEMENT

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

Also known as: Placebo D3

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Secondary hyperparathyroidism due to Vitamin D deficiency

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus, 8000, Denmark

Location

Related Publications (3)

• Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.

  PMID: 35018442 DERIVED

• Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Bone Microstructure in Response to Vitamin D3 Supplementation: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2019 Feb;104(2):160-170. doi: 10.1007/s00223-018-0481-6. Epub 2018 Oct 6.

  PMID: 30293198 DERIVED

• Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Effects of Vitamin D3 Supplementation on Muscle Strength, Mass, and Physical Performance in Women with Vitamin D Insufficiency: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2018 Nov;103(5):483-493. doi: 10.1007/s00223-018-0443-z. Epub 2018 Jun 21.

  PMID: 29931459 DERIVED

MeSH Terms

Conditions

Osteoporosis; Vitamin D Deficiency; Cardiovascular Diseases

Interventions

Valsartan; Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Lars Rejnmark, Professor

  Department of Endocrinology and Internal medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 9, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 15, 2018

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)