The Effect of a Meal on Vitamin D Absorption

May 9, 2013 updated by: Bess Dawson-Hughes, Tufts University

Meal Effects on the 25OHD3 Response to Supplemental Vitamin D3

This study seeks to determine if vitamin D3 absorption in healthy adults will be enhanced in the presence of a meal and if the enhancement will be greater when the meal is low as opposed to high in fat content. The enhancement will result from increased vitamin D absorption. The investigators will test this hypothesis by pursuing the following aims in a 3-mo trial in which up to 70 healthy men and women will be randomized to one of the following meal conditions under which they will take a monthly oral dose of 50,000 IU of vitamin D3: no meal (fasting), a low fat meal, or a high fat meal. The Primary Aim is to identify the meal condition (fasting, low-fat, or high-fat meal) under which the 25OHD3 response to supplemental vitamin D3 is greatest and most consistent. The Secondary Aim is to determine whether vitamin D3 absorption is affected by the meal condition and to determine whether the absorption of vitamin D3 predicts the longer-term 25OHD3 response to supplementation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin D supplements are increasingly recommended to curb widespread deficiency. Decreasing the variability in 25OHD responses to supplemental vitamin D would make the supplementation process more predictable, and thereby reduce the number of 25OHD measurements and dose adjustments that are needed to achieve the targeted 25OHD level. This study seeks to identify potential sources of variability in the 25OHD3 response to supplemental vitamin D3 that are plausible based on rat studies, but have not been explored in humans. The investigators hypothesize that the serum 25OHD3 response to supplemental vitamin D3 in healthy adults will be enhanced in the presence of a meal and the enhancement will be greater when the meal is low as opposed to high in fat content. The enhancement will result from increased vitamin D absorption. The investigators will test this hypothesis by pursuing the following aims in a 3-mo trial in which up to 70 healthy men and women will be randomized to one of the following meal conditions under which they will take a monthly oral dose of 50,000 IU of vitamin D3: no meal (fasting), a low fat meal, or an iso-caloric high fat meal. Serum 25OHD3 will be measured at baseline and after 1 and 3 mo. A serum vitamin D3 absorption test will be performed in each subject after the first dose of vitamin D. The Primary Aim is to identify the meal condition (fasting, low-fat, or high-fat meal) under which the 25OHD3 response to supplemental vitamin D3 is greatest and most consistent. The Secondary Aim is to determine whether vitamin D3 absorption is affected by the meal condition and to determine whether the absorption of vitamin D3 predicts the longer-term 25OHD3 response to supplementation.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 50 to 69
  • BMI ≥ 18.5 and ≤ 27.9 kg/m2
  • those taking ≤ 400 IU/day of vitamin D3 and ≤ 1000 mg calcium/day
  • those who participate must agree not to change their dietary or supplemental vitamin D or calcium intake during the study
  • no use of tanning salons
  • no travel south of latitude 34 degrees north during the study

Exclusion Criteria:

General:

  1. A screening 25OHD level ≤8 or ≥ 25 ng/ml
  2. An abnormal serum calcium (reference range is 8.3 -10.2 mg/dl)
  3. A screening spot urinary calcium:creatinine ratio > 0.325
  4. Greater than 2 drinks of alcohol a day.
  5. BMI <18.5 and >27.9 kg/m2
  6. Menses within the last year (women)
  7. Age <50 and > 69 years
  8. Allergy to egg
  9. A blood donation in the last 2 months (increases likelihood of anemia)
  10. Non-English speaking subjects will not be enrolled.
  11. Other abnormalities in screening labs, at the discretion of the study physician (PI)

Medications:

  1. Subjects must agree not to take more than 400 IU per day of vitamin D as supplement or cod liver oil during the study
  2. Topical vitamin D preparations
  3. Oral estrogen or estrogen patch use in the last 6 months
  4. Regular antacid use (>2 times per week)
  5. Sucralfate
  6. Acarbose/miglitol
  7. PPIs - prescription: lansoprazole (Prevacid), omeprazole (Prilosec and Zegerid), esomeprazole (Nexium), rabeprazole (Aciphex), pantoprazole (Protonix); over-the-counter: lansoprazole (Prevacid 24), omeprazole (Prilosec OTC), zegerid OTC (Equate), omeprazole magnesium
  8. H2 blockers - prescription: cimetidine (Tagamet), famotidine (Pepsid), nizatidine (Axid), rantidine hydrochloride (Zantac), dexlansoprazole (Kapidex); over the counter: cimetidine (Tagamet-HB, Equate), famotidine (Pepcid-AC, Pepcid Complete), rantidine hydrochloride (Zantac, Wal-Zan, Equate)
  9. Drugs that alter fat and cholesterol handling - xenical and alli (Orlistat), cholestyramine (Questran, LoCholest, Prevalite), Zetia
  10. Drugs that alter 25OHD metabolism - Antiseizure drugs phenobarbitol and phenytoin (Dilantin), oral glucocorticoids
  11. Calcium supplement use >1000 mg/day

Diseases:

  1. Active parathyroid disease
  2. Sarcoidosis
  3. Peptic ulcers or esophageal stricture
  4. Active malignancy (other than basal cell cancer of the skin) or cancer therapy in the last year
  5. Advanced kidney disease (creatinine clearance <30 ml/min calculated from serum creatinine with use of the Modification of Diet in Renal Disease (MDRD) Study equation
  6. Kidney stones in the last 5 years.
  7. Liver disease
  8. Zollinger-Ellison syndrome
  9. Known achlorhydria or small bowel overgrowth
  10. Malabsorption
  11. Diseases associated with fat malabsorption - liver disease, cystic fibrosis, Celiac disease, bariatric surgery, Scleroderma, Crohn's, prior surgery involving the stomach or small bowel (appendectomy okay), gall stones or prior gall bladder surgery, pancreatitis

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low fat meal
Those subjects who receive a low fat meal prior to vitamin D3 administration
Dietary supplement: cholecalciferol
50,000 IU once per month for 3 months
Other Names:
  • vitamin D3
Active Comparator: High fat meal
Those subjects who receive a high fat meal prior to vitamin D3 administration
Dietary supplement: cholecalciferol
50,000 IU once per month for 3 months
Other Names:
  • vitamin D3
Active Comparator: No meal
Those subjects who do not receive a meal and continue to fast. They only receive the vitamin D3 dose.
Dietary supplement: cholecalciferol
50,000 IU once per month for 3 months
Other Names:
  • vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
25OHD3 response to supplemental vitamin D3
Time Frame: 3 months
To identify the meal condition (fasting, low-fat, or high-fat meal) under which the 25OHD3 response to supplemental vitamin D3 is greatest and most consistent, specifically, to describe and compare changes in serum 25OHD3 concentration across the 3 groups.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in parent vitamin D3 levels
Time Frame: 12 hours
To determine whether vitamin D3 absorption is affected by the meal condition, specifically,a) to describe and compare the change in parent vitamin D3 levels over the 12-hr period following the first dose of vitamin D3 across the 3 groups and b) to determine whether the absorption of vitamin D3 at 12 hours predicts the longer-term 25OHD3 response to supplementation.
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Bess Dawson-Hughes, M.D., Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 28, 2010

First Submitted That Met QC Criteria

December 28, 2010

First Posted (Estimate)

December 29, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2660

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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