Status:
COMPLETED
A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption
Lead Sponsor:
Tufts University
Collaborating Sponsors:
Pfizer
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs. poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken after that meal. ...
Detailed Description
There is evidence that vitamin D has a favorable effect on bone and muscle. Many adults have low blood levels of 25-hydroxyvitamin D (25OHD) and consequently, vitamin D supplements are being widely re...
Eligibility Criteria
Inclusion
- Caucasian men and women age 50 years and older
- Women must be at least 1 year since last menses
- Subjects must agree not to attend a tanning salon or increase their sun exposure between the screening and final study visits and, for those in the higher vitamin D dose group (50,800 IU), for one month after they have completed the study.
- Subjects must agree not to take more than 400 IU of vitamin D (the amount in most multivitamins) or 1000 mg of calcium per day as their own supplements between the screening and final study visits and, for those in the higher vitamin D dose group (50,800 IU), for one month after completing the study (Note: no supplemental calcium or vitamin D is allowed on the study day.
- Screening serum 25OHD of 25 to 29.5 ng/ml
- Screening BMI 20 to 29.5 kg/m2
- Screening plasma triglyceride concentrations below 150 mg/dL
Exclusion
- Uncontrolled type 2 diabetes with fasting blood sugar \>140 mg/dl
- GFR \< 30 ml/min calculated from serum creatinine with use of the Modification of Diet in Renal Disease (MDRD) Study equation \[7\]
- Screening fasting spot urinary calcium:creatinine ratio (Ca:Cr) \> 0.325 (corresponding to a 24-hr urine calcium of 350 mg)
- Screening serum calcium exceeding upper normal limit (reference range 8.3 -10.2 mg/dl)
- Other abnormalities in screening labs, at the discretion of the study physician (PI)
- Sarcoidosis
- Malabsorption, Crohn's disease
- Subjects with disorders of bone and mineral metabolism
- Kidney stones - in the last 3 years
- Evidence of chronic liver disease, including alcoholism
- Cancer treatment in the last year (except basal cell carcinoma) or terminal illness
- Use of lipid lowering medications, plant sterols, fish oil, or flaxseed oil
- Treatment in the last 6 months with estrogen, raloxifene, calcitonin, or testosterone (vaginal estrogen okay)
- Treatment in the last year with teriparatide or denosumab
- Treatment in the last 2 years with bisphosphonates
- Oral corticosteroid therapy for over 3 weeks within the last 6 months
- Anticonvulsant therapy
- High dose thiazide therapy (\>37.5 mg per day)
- Allergy to egg
- Non-English speaking subjects (The food frequency questionnaire to be used in this study has not been validated in other languages. Thus, their diet data would not be able to be included in the analyses. As such, it is inappropriate to expose non-English speaking participants to the study risks, however small, when their data will not contribute to the study results.)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01508845
Start Date
January 1 2012
End Date
June 1 2013
Last Update
July 21 2014
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111