The Effect of a Meal on Vitamin D Absorption
Completed · Phase 1
Conditions studied: Vitamin D Deficiency
In brief
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.
Key facts
- Study ID
- NCT01268176
- Run by
- Tufts University
- People needed
- 62
- Starts
- 2010-12-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2013-05-13
Who can join
Age: 50 and older, up to 69. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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:
Where it is running
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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