Does Treatment of Hypovitaminosis D Increase Calcium Absorption?

NCT00581828 | Completed Phase 4 Results DMC

• 2 other identifiers: 2005-015905-1235-02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass, functional status, measures of physical function and quality of life. I hypothesize that treatment of hypovitaminosis D results in improved intestinal calcium absorption, greater retention of calcium within the bone reservoir and improved physical function, quality of life and muscle mass.

Conditions

Osteoporosis; Osteopenia; Vitamin D Deficiency; Hypoparathyroidism; Hypercalciuria; Hypercalcemia

Keywords

Calcium Absorption; Intestinal Absorption of Calcium; Fractional Calcium Absorption; Stable Calcium Isotopes; Hypovitaminosis D; Vitamin D; Bone Mineral Density; Physical Function

Outcome Measures

Primary Outcomes (1)

• Change in Intestinal Calcium Absorption From Baseline to One Month

  percent and true fractional calcium absorption

  1 month

Study Arms (1)

1

EXPERIMENTAL

Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).

Drug: Vitamin D

Interventions

Vitamin D DRUG

50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year)

Also known as: Vitamin D2, Ergocalciferol

1

Eligibility Criteria

• Age: 50 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer MM. Vitamin D insufficiency: disease or no disease? J Bone Miner Res. 2008 Jul;23(7):1052-60. doi: 10.1359/jbmr.080230.

  PMID: 18302509 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Vitamin D Deficiency; Hypoparathyroidism; Hypercalciuria; Hypercalcemia

Interventions

Vitamin D; Ergocalciferols

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Parathyroid Diseases; Endocrine System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr Karen Hansen
• Organization: University of Wisconsin

keh@medicine.wisc.edu

608-263-3457

Study Officials

• Karen E Hansen, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: January 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 24, 2023
• Results First Posted: September 14, 2012

Record last verified: 2012-09

Locations

US (1)