Skip to main content
OpenTrials
Completed

NCT Number: NCT00754442

Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism

The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney function.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Medicine Division of Endocrinology

Baltimore, Maryland, 21201, United States

About this study

Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it. Vitamin D must then be activated by both the liver and the kidneys to perform its function of maintaining strong bones and helping to prevent heart disease, infection, diabetes and cancer. Reduced kidney activation of Vitamin D occurs with advanced age and with all kidney diseases. We have identified a small group of patients who appear to have reduced ability of the kidneys to activate vitamin D, even though they are young and do not have chronic kidney disease. In these patients, we are comparing the ability of their kidneys to activate Vitamin D to that of healthy controls. To stimulate the kidneys to activate Vitamin D, we are giving parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4 and 8 hours. This type of parathyroid infusion does not cause side effects. The gene that controls this activation is also being studied (by a simple blood test) to look for abnormalities. We are now actively recruiting healthy controls for this study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caucasian female
  • Age 40-59 years
  • Serum creatinine < 1.3 and estimated glomerular filtration rate (GRF) > 60
  • Serum calcium in the normal range (for U Md lab 8.6-10 mg/dl)
  • Parathyroid hormone in the normal range (for U Md lab 12-54 pg/ml)
  • Normal 25-hydroxyvitamin D level (30 ng/ml or higher)
  • For women of childbearing age, non-pregnant (based on negative urine pregnancy test on the morning of the teriparatide infusion)

Exclusion criteria

  • Non-caucasian
  • Age under 40 and over 59 years
  • Male
  • Serum creatinine over 1.3 or estimated glomerular filtration rate (GFR) < 60
  • Abnormal serum calcium (for U Md lab, below 8.6 or above 10 mg/dl)
  • Abnormal parathyroid hormone (for U Md lab, above 65 or below 12 pg/ml)
  • For women of childbearing age, non-pregnant (based on urine pregnancy test on the morning of the teriparatide infusion)
  • History of bone radiation
  • History of Paget disease of bone
  • History of bone malignancy or metastases
  • History of allergy or sensitivity to Forteo

Treatment and study plan

Teriparatide

Drug

Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls"

Other names: Forteo

Primary outcomes

  1. The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours

    Time frame: baseline, 4 and 8 hours after start of infusion

    1,25-D was measured at baseline, 4 and 8 hours after PTH infusion

Secondary outcomes

  1. The Number of Patients With Mutations in CYP27B1

    Time frame: blood samples taken at baseline and sequenced over several days

    CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Clinical and Molecular Characterization of Suspected Partial 25-hydroxyvitamin D-1-alpha-hydroxylase Deficiency

Acronym: 1hydroxylase

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 18, 2008
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.