The Effect of a Meal on Vitamin D Absorption

NCT01268176

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

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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
50-69 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


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

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Vitamin D DeficiencyThe Effect of a Meal on Vitamin D Absorption
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Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect of a Meal on Vitamin D Absorption
Official Title  ICMJE Meal Effects on the 25OHD3 Response to Supplemental Vitamin D3
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE Dietary Supplement: cholecalciferol
50,000 IU once per month for 3 months
Other Name: vitamin D3
Study Arms  ICMJE
  • Active Comparator: Low fat meal
    Those subjects who receive a low fat meal prior to vitamin D3 administration
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: High fat meal
    Those subjects who receive a high fat meal prior to vitamin D3 administration
    Intervention: Dietary Supplement: cholecalciferol
  • Active Comparator: No meal
    Those subjects who do not receive a meal and continue to fast. They only receive the vitamin D3 dose.
    Intervention: Dietary Supplement: cholecalciferol
Publications *

*   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: May 9, 2013)
62
Original Estimated Enrollment  ICMJE
 (submitted: December 28, 2010)
70
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 69 Years   (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 NCT01268176
Other Study ID Numbers  ICMJE 2660
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bess Dawson-Hughes, 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 May 2013

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