The Effect of a Meal on Vitamin D Absorption

NCT01268176 | Completed Phase 1

• 1 other identifier: 2660
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; vitamin D deficiency; vitamin D absorption

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Change in parent vitamin D3 levels

  12 hours

Study Arms (3)

Low fat meal

ACTIVE COMPARATOR

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

Dietary Supplement: cholecalciferol

High fat meal

ACTIVE COMPARATOR

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

Dietary Supplement: cholecalciferol

No meal

ACTIVE COMPARATOR

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

Dietary Supplement: cholecalciferol

Interventions

cholecalciferol DIETARY_SUPPLEMENT

50,000 IU once per month for 3 months

Also known as: vitamin D3

High fat meal; Low fat meal; No meal

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tufts University: lead
• Pfizer: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Publications (9)

• 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.

  PMID: 19302999 BACKGROUND

• 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.

  PMID: 8988915 BACKGROUND

• 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.

  PMID: 12499343 BACKGROUND

• 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.

  PMID: 15776217 BACKGROUND

• 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.

  PMID: 25826 BACKGROUND

• 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.

  PMID: 20200983 BACKGROUND

• 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.

  PMID: 2594036 BACKGROUND

• 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.

  PMID: 18408879 BACKGROUND

• 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.

  PMID: 11157326 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Bess Dawson-Hughes, M.D.

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bone Metabolism Laboratory

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 29, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

US (1)