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

NCT01508845

Last updated date
Study Location
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vitamin D Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Vitamin D DeficiencyA Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption
NCT01508845
  1. Boston, Massachusetts
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Vitamin D DeficiencyThe Effect of a Meal on Vitamin D Absorption
NCT01268176
  1. Boston, Massachusetts
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption
Official Title  ICMJE A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption
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.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Dietary Supplement: cholecalciferol
    800 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose
    Other Name: vitamin D3
  • Dietary Supplement: cholecalciferol
    50,000 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose
    Other Name: vitamin D3
  • Dietary Supplement: cholecalciferol
    50,000 IU vitamin D3, 1 dose; 800 IU vitamin D3, 1 dose
    Other Name: vitamin D3
Study Arms  ICMJE
  • Active Comparator: High MUFA/PUFA, 1600 IU vitamin D3
    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
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: High MUFA/PUFA, 50,800 IU vitamin D3
    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
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: Low MUFA/PUFA, 50,800 IU vitamin D3
    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
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: Fat free meal, 50,800 IU vitamin D3
    Subjects will receive 3 fat-free meals (1 day) and 50,000 IU vitamin D3 and 800 IU of deuterated vitamin D3
    Intervention: Dietary Supplement: cholecalciferol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2014)
61
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2012)
65
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01508845
Other Study ID Numbers  ICMJE 2730
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tufts University
Study Sponsor  ICMJE Tufts University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Bess Dawson-Hughes, M.D.Tufts Medical Center
PRS Account Tufts University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP