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

NCT01508845 | Completed

• 1 other identifier: 2730
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Vitamin D Deficiency

Keywords

vitamin D; vitamin D absorption; vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

• The rate of vitamin D3 absorption after consuming meals with 3 different ratios of MUFA/PUFA content.

  10, 12 and 14 hours

Secondary Outcomes (1)

• The association between changes in plasma D3 and fatty acid profiles, specifically MUFAs.

  10, 12 and 14 hours

Study Arms (4)

High MUFA/PUFA, 1600 IU vitamin D3

ACTIVE COMPARATOR

Subjects will receive 3 meals (1 day) with a high MUFA/PUFA ratio (20g/5g), along with 800 IU of vitamin D3 and 800 IU of deuterated vitamin D3

Dietary Supplement: cholecalciferol

High MUFA/PUFA, 50,800 IU vitamin D3

ACTIVE COMPARATOR

Subjects will receive 3 meals (1 day) with a high MUFA/PUFA ratio (20g/5g), along with 50,000 IU of vitamin D3 and 800 IU of deuterated vitamin D3

Dietary Supplement: cholecalciferol

Low MUFA/PUFA, 50,800 IU vitamin D3

ACTIVE COMPARATOR

Subjects will receive 3 meals (1 day) with a low MUFA/PUFA ratio (5g/20g), along with 50,000 IU of vitamin D3 and 800 IU of deuterated vitamin D3

Dietary Supplement: cholecalciferol

Fat free meal, 50,800 IU vitamin D3

ACTIVE COMPARATOR

Subjects will receive 3 fat-free meals (1 day) and 50,000 IU vitamin D3 and 800 IU of deuterated vitamin D3

Dietary Supplement: cholecalciferol

Interventions

cholecalciferol DIETARY_SUPPLEMENT

800 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose

Also known as: vitamin D3

High MUFA/PUFA, 1600 IU vitamin D3

Eligibility Criteria

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

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

Sponsors & Collaborators

• Tufts University: lead
• Pfizer: collaborator

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bess Dawson-Hughes, M.D.

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 21, 2014

Record last verified: 2014-07

Locations

US (1)