Phase 4
N=230
Treatment of Vitamin D Insufficiency
Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00933244 ↗Enrolled (actual)
230
Serious AEs
7.4%
Results posted
Nov 2015
Primary outcome: Primary: Intestinal Calcium Absorption — 0.200; 0.217; 0.183; 0.206 Total Fractional Calcium Absorption
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- High Dose Vitamin D3 (Dietary_supplement); Low Dose Vitamin D3 (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intestinal Calcium Absorption |
0.200; 0.217; 0.183; 0.206; 0.172; 0.174 | — |
| SECONDARY Bone Mineral Density |
-0.3; 0.0; 0.2; -0.2; -0.5; -0.9 | — |
Summary
The purpose of this study is to answer the following questions: Does vitamin D increase calcium absorption, bone mass and muscle mass and function in women past menopause who have mildly low vitamin D levels? Do these benefits require prescription-strength vitamin D, or is an over the counter vitamin D dose enough?
Eligibility Criteria
Inclusion Criteria
- Vitamin D insufficiency, defined as a serum 25(OH)D 16 to 25 ng/mL by high performance liquid chromotography assay
- Women ≥ 5 years past the date of last menses or bilateral oophorectomy, or ≥ 60 years old if they had prior hysterectomy without bilateral oophorectomy
- Total dietary and supplemental calcium intake 75 years old
- Hypercalcemia (serum calcium corrected for albumin > 10.4 mg/dL)
- Nephrolithiasis by medical record or patient report
- Inflammatory bowel disease, malabsorption or chronic diarrhea
- Stage 3, 4 or 5 Chronic Kidney Disease based on the Modification of Renal Diet (MDRD) formula
- Use of bone-active medications within the past 6 months including bisphosphonates, estrogen compounds, calcitonin, teriparatide, oral corticosteroids and anticonvulsants
- Allergy or intolerance to orange juice
- Allergy or intolerance to sunscreen
- Prior adult clinical fragility fracture of the hip, spine or wrist or a T-score below -2.5 at the lumbar spine or femur
Data sourced from ClinicalTrials.gov (NCT00933244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.