A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption

Completed · Not applicable

Conditions studied: Vitamin D Deficiency

In brief

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. The study hypothesis is that vitamin D3 absorption will be greater when fat is present vs. absent in the meal. A secondary hypothesis is that vitamin D3 absorption will be greater in the presence of a meal with a high MUFA/PUFA compared with a low MUFA/PUFA ratio.

Key facts

Study ID

NCT01508845

Run by

Tufts University

People needed

61

Starts

2012-01-01

Expected to finish

2013-06-01

Last updated by the study team

2014-07-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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