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The Effect of a Meal on Vitamin D Absorption

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D, vitamin D deficiency, vitamin D absorption

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Low fat meal

High fat meal

No meal

Arm Description

Those subjects who receive a low fat meal prior to vitamin D3 administration

Those subjects who receive a high fat meal prior to vitamin D3 administration

Those subjects who do not receive a meal and continue to fast. They only receive the vitamin D3 dose.

Outcomes

Primary Outcome Measures

25OHD3 response to supplemental vitamin D3
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.

Secondary Outcome Measures

Change in parent vitamin D3 levels
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.

Full Information

First Posted
December 28, 2010
Last Updated
May 9, 2013
Sponsor
Tufts University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01268176
Brief Title
The Effect of a Meal on Vitamin D Absorption
Official Title
Meal Effects on the 25OHD3 Response to Supplemental Vitamin D3
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D, vitamin D deficiency, vitamin D absorption

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low fat meal
Arm Type
Active Comparator
Arm Description
Those subjects who receive a low fat meal prior to vitamin D3 administration
Arm Title
High fat meal
Arm Type
Active Comparator
Arm Description
Those subjects who receive a high fat meal prior to vitamin D3 administration
Arm Title
No meal
Arm Type
Active Comparator
Arm Description
Those subjects who do not receive a meal and continue to fast. They only receive the vitamin D3 dose.
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
vitamin D3
Intervention Description
50,000 IU once per month for 3 months
Primary Outcome Measure Information:
Title
25OHD3 response to supplemental vitamin D3
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in parent vitamin D3 levels
Description
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.
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: A screening 25OHD level ≤8 or ≥ 25 ng/ml An abnormal serum calcium (reference range is 8.3 -10.2 mg/dl) A screening spot urinary calcium:creatinine ratio > 0.325 Greater than 2 drinks of alcohol a day. BMI <18.5 and >27.9 kg/m2 Menses within the last year (women) Age <50 and > 69 years Allergy to egg A blood donation in the last 2 months (increases likelihood of anemia) Non-English speaking subjects will not be enrolled. Other abnormalities in screening labs, at the discretion of the study physician (PI) Medications: Subjects must agree not to take more than 400 IU per day of vitamin D as supplement or cod liver oil during the study Topical vitamin D preparations Oral estrogen or estrogen patch use in the last 6 months Regular antacid use (>2 times per week) Sucralfate Acarbose/miglitol 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 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) Drugs that alter fat and cholesterol handling - xenical and alli (Orlistat), cholestyramine (Questran, LoCholest, Prevalite), Zetia Drugs that alter 25OHD metabolism - Antiseizure drugs phenobarbitol and phenytoin (Dilantin), oral glucocorticoids Calcium supplement use >1000 mg/day Diseases: Active parathyroid disease Sarcoidosis Peptic ulcers or esophageal stricture Active malignancy (other than basal cell cancer of the skin) or cancer therapy in the last year 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 Kidney stones in the last 5 years. Liver disease Zollinger-Ellison syndrome Known achlorhydria or small bowel overgrowth Malabsorption 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bess Dawson-Hughes, M.D.
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19302999
Citation
Fu L, Yun F, Oczak M, Wong BY, Vieth R, Cole DE. Common genetic variants of the vitamin D binding protein (DBP) predict differences in response of serum 25-hydroxyvitamin D [25(OH)D] to vitamin D supplementation. Clin Biochem. 2009 Jul;42(10-11):1174-7. doi: 10.1016/j.clinbiochem.2009.03.008. Epub 2009 Mar 18.
Results Reference
background
PubMed Identifier
8988915
Citation
Dawson-Hughes B, Harris SS, Dallal GE. Plasma calcidiol, season, and serum parathyroid hormone concentrations in healthy elderly men and women. Am J Clin Nutr. 1997 Jan;65(1):67-71. doi: 10.1093/ajcn/65.1.67.
Results Reference
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PubMed Identifier
12499343
Citation
Heaney RP, Davies KM, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. Am J Clin Nutr. 2003 Jan;77(1):204-10. doi: 10.1093/ajcn/77.1.204. Erratum In: Am J Clin Nutr. 2003 Nov;78(5):1047.
Results Reference
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PubMed Identifier
15776217
Citation
Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporos Int. 2005 Jul;16(7):713-6. doi: 10.1007/s00198-005-1867-7. Epub 2005 Mar 18.
Results Reference
background
PubMed Identifier
25826
Citation
Hollander D, Muralidhara KS, Zimmerman A. Vitamin D-3 intestinal absorption in vivo: influence of fatty acids, bile salts, and perfusate pH on absorption. Gut. 1978 Apr;19(4):267-72. doi: 10.1136/gut.19.4.267.
Results Reference
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PubMed Identifier
20200983
Citation
Mulligan GB, Licata A. Taking vitamin D with the largest meal improves absorption and results in higher serum levels of 25-hydroxyvitamin D. J Bone Miner Res. 2010 Apr;25(4):928-30. doi: 10.1002/jbmr.67.
Results Reference
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PubMed Identifier
2594036
Citation
Krall EA, Sahyoun N, Tannenbaum S, Dallal GE, Dawson-Hughes B. Effect of vitamin D intake on seasonal variations in parathyroid hormone secretion in postmenopausal women. N Engl J Med. 1989 Dec 28;321(26):1777-83. doi: 10.1056/NEJM198912283212602.
Results Reference
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PubMed Identifier
18408879
Citation
Rockell JE, Skeaff CM, Williams SM, Green TJ. Association between quantitative measures of skin color and plasma 25-hydroxyvitamin D. Osteoporos Int. 2008 Nov;19(11):1639-42. doi: 10.1007/s00198-008-0620-4. Epub 2008 Apr 12.
Results Reference
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PubMed Identifier
11157326
Citation
Vieth R, Chan PC, MacFarlane GD. Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level. Am J Clin Nutr. 2001 Feb;73(2):288-94. doi: 10.1093/ajcn/73.2.288.
Results Reference
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The Effect of a Meal on Vitamin D Absorption

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