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The Effect of a Meal on Vitamin D Absorption

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bess Dawson-Hughes, Tufts University
ClinicalTrials.gov Identifier:
NCT01268176
First received: December 28, 2010
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
 Dietary Supplement: cholecalciferol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Meal Effects on the 25OHD3 Response to Supplemental Vitamin D3

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • 25OHD3 response to supplemental vitamin D3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 62
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: vitamin D3

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.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268176

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Pfizer
Investigators
Principal Investigator: Bess Dawson-Hughes, M.D. Tufts Medical Center
  More Information

Publications:

Responsible Party: Bess Dawson-Hughes, Director, Bone Metabolism Laboratory, Tufts University
ClinicalTrials.gov Identifier: NCT01268176     History of Changes
Other Study ID Numbers: 2660
Study First Received: December 28, 2010
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
Vitamin D
vitamin D deficiency
vitamin D absorption

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013