Completed

MUFA/PUFAA Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption

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What is being tested

cholecalciferol

Dietary Supplement
Who is being recruted

Avitaminosis+3

+ Deficiency Diseases

+ Nutrition Disorders

Over 50 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorTufts University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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 recommended. The effect of a meal on the absorption of vitamin D is poorly understood. This single blind study will examine whether the amount and type of fat in the meal with which vitamin D is taken influences its absorption. Vitamin D dissolves in fat and so dietary fat may affect its absorption; moreover the type of fat with respect to mono- and poly-unsaturation may also influence absorption. This study should increase our understanding of how best to take vitamin D in order to achieve maximal absorption. Up to 65 healthy older men and women with 25OHDlevels in the insufficient range will be enrolled in order to get 60 completers in this 1-day study. They will randomized to one of three meal groups: high MUFA/PUFA (n=30), low MUFA/PUFA (n=15), or fat-free (n=15). Those in the high MUFA/PUFA group will also be randomized to a single dose of either 1,600 or 50,800 IU of vitamin D. All participants in the other two groups will receive the 50,800 IU dose. They will consume only the three meals provided during the study day. In the morning they will come to the Center for a blood draw, to consume their breakfast meal, and to take their assigned dose of vitamin D (part of which is labeled with the non-radioactive tracer, deuterium to enable direct assessment of vitamin D absorption). They will also complete questionnaires about their diet and health and have a DXA total body scan. They will be given a boxed lunch to eat at noon. They will return to HNRCA for blood draws at 6:00, 8:00, and 10:00 pm. They will have dinner at HNRCA after the 6:00 pm blood draw. They finish the study after the final blood draw. Participants who receive the higher dose of vitamin D, 50,800 IU, will be asked not to take more than 400 IU of vitamin D or 1000 mg per day of supplemental calcium or attend tanning salons for the month after completing the study, in order to minimize any risk of symptoms from the vitamin D. Blood draws include screening visit 20 cc, morning visit 15 cc, and three evening blood draws of 15, 15, and 15 cc, respectively, total 80 cc.

Official TitleA Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption
Principal SponsorTufts University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AvitaminosisDeficiency DiseasesNutrition DisordersNutritional and Metabolic DiseasesVitamin D DeficiencyMalnutrition

Criteria

7 inclusion criteria required to participate
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.

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20 exclusion criteria prevent from participating
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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Boston, United StatesOpen Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Google Maps
CompletedOne Study Center