Does Treatment of Hypovitaminosis D Increase Calcium Absorption?

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT00581828
• Date of registration: 19/12/2007
• Prospective Registration: No
• Primary sponsor: University of Wisconsin, Madison
• Public title: Does Treatment of Hypovitaminosis D Increase Calcium Absorption?
• Scientific title: Does Treatment of Hypovitaminosis D Increase Calcium Absorption?
• Date of first enrolment: January 2005
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00581828
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Karen E Hansen, MD
• Affiliation: University of Wisconsin, Madison

Key inclusion & exclusion criteria

Inclusion Criteria:

- women at least five years past onset of menopause, defined as date of last menses
(ages reported above are the range in ages of the participants recruited to the study)

- serum 25(OH)D 16-24 ng/ml by reverse phase HPLC

- calcium intake < or = 1,100 mg daily

Exclusion Criteria:

- Intake of >1,100 mg of calcium per day through the combination of diet and supplements

- Hypercalcemia (baseline serum calcium above the normal reference range)

- Nephrolithiasis, documented in the medical record or by patient report

- Inflammatory bowel disease, malabsorption, chronic diarrhea, or use of antibiotics
within the past month

- Creatinine >2.0 mg/dL

- Hypercalciuria (baseline urine calcium: creatinine ratio >0.25)

- Current use of medications known to interfere with vitamin D and/or calcium
metabolism, including oral steroids or anticonvulsants

- Ongoing or recent (past six months) use of bisphosphonates, estrogen compounds,
calcitonin or teriparatide, as these compounds may independently affect retention of
calcium within bone

- Diagnosis of, or evidence for, osteomalacia, manifest by serum 25(OH)D < 16 ng/ml or
the presence of at least two of the following blood tests: low calcium, low
phosphorus, or elevated alkaline phosphatase (23).

- Prior adult clinical fragility fracture or baseline T-score below -3.0 at the lumbar
spine or femur



Age minimum: 50 Years
Age maximum: 66 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Osteoporosis

Hypercalcemia

Hypoparathyroidism

Osteopenia

Vitamin D Deficiency

Hypercalciuria

Intervention(s)

Drug: Vitamin D

Primary Outcome(s)

Change in Intestinal Calcium Absorption From Baseline to One Month [Time Frame: 1 month]

Secondary ID(s)

05-1235-02

2005-0159

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/09/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00581828