Does Treatment of Hypovitaminosis D Increase Calcium Absorption?

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• women at least five years past onset of menopause, defined as date of last menses

• 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