Vitamin D DeficiencyMUFA/PUFANCT01508845
A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption
A study testing cholecalciferol in people with Vitamin D Deficiency, run by Tufts University at 1 site in United States.
Trial summary
This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs. poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken after that meal. The study hypothesis is that vitamin D3 absorption will be greater when fat is present vs. absent in the meal. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian men and women age 50 years and older
- Women must be at least 1 year since last menses
- Subjects must agree not to attend a tanning salon or increase their sun exposure between the screening and final study visits and, for those in the higher vitamin D dose group (50,800 IU), for one month after they have completed the study.
- Subjects must agree not to take more than 400 IU of vitamin D (the amount in most multivitamins) or 1000 mg of calcium per day as their own supplements between the screening and final study visits and, for those in the higher vitamin D dose group (50,800 IU), for one month after completing the study (Note: no supplemental calcium or vitamin D is allowed on the study day.
- Screening serum 25OHD of 25 to 29.5 ng/ml
- Screening BMI 20 to 29.5 kg/m2
- Screening plasma triglyceride concentrations below 150 mg/dL
Who cannot join
- Uncontrolled type 2 diabetes with fasting blood sugar >140 mg/dl
- GFR < 30 ml/min calculated from serum creatinine with use of the Modification of Diet in Renal Disease (MDRD) Study equation [7]
- Screening fasting spot urinary calcium:creatinine ratio (Ca:Cr) > 0.325 (corresponding to a 24-hr urine calcium of 350 mg)
- Screening serum calcium exceeding upper normal limit (reference range 8.3 -10.2 mg/dl)
- Other abnormalities in screening labs, at the discretion of the study physician (PI)
- Sarcoidosis
Show all 20Show fewer
- Malabsorption, Crohn's disease
- Subjects with disorders of bone and mineral metabolism
- Kidney stones - in the last 3 years
- Evidence of chronic liver disease, including alcoholism
- Cancer treatment in the last year (except basal cell carcinoma) or terminal illness
- Use of lipid lowering medications, plant sterols, fish oil, or flaxseed oil
- Treatment in the last 6 months with estrogen, raloxifene, calcitonin, or testosterone (vaginal estrogen okay)
- Treatment in the last year with teriparatide or denosumab
- Treatment in the last 2 years with bisphosphonates
- Oral corticosteroid therapy for over 3 weeks within the last 6 months
- Anticonvulsant therapy
- High dose thiazide therapy (>37.5 mg per day)
- Allergy to egg
- Non-English speaking subjects (The food frequency questionnaire to be used in this study has not been validated in other languages. Thus, their diet data would not be able to be included in the analyses. As such, it is inappropriate to expose non-English speaking participants to the study risks, however small, when their data will not contribute to the study results.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs. poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken after that meal. The study hypothesis is that vitamin D3 absorption will be greater when fat is present vs. absent in the meal. A secondary hypothesis is that vitamin D3 absorption will be greater in the presence of a meal with a high MUFA/PUFA compared with a low MUFA/PUFA ratio.
Read the detailed description
There is evidence that vitamin D has a favorable effect on bone and muscle. Many adults have low blood levels of 25-hydroxyvitamin D (25OHD) and consequently, vitamin D supplements are being widely recommended. The effect of a meal on the absorption of vitamin D is poorly understood. This single blind study will examine whether the amount and type of fat in the meal with which vitamin D is taken influences its absorption. Vitamin D dissolves in fat and so dietary fat may affect its absorption; moreover the type of fat with respect to mono- and poly-unsaturation may also influence absorption. This study should increase our understanding of how best to take vitamin D in order to achieve maximal absorption. Up to 65 healthy older men and women with 25OHDlevels in the insufficient range will be enrolled in order to get 60 completers in this 1-day study. They will randomized to one of three meal groups: high MUFA/PUFA (n=30), low MUFA/PUFA (n=15), or fat-free (n=15). Those in the high MUFA/PUFA group will also be randomized to a single dose of either 1,600 or 50,800 IU of vitamin D. All participants in the other two groups will receive the 50,800 IU dose. They will consume only the three meals provided during the study day. In the morning they will come to the Center for a blood draw, to consume their breakfast meal, and to take their assigned dose of vitamin D (part of which is labeled with the non-radioactive tracer, deuterium to enable direct assessment of vitamin D absorption). They will also complete questionnaires about their diet and health and have a DXA total body scan. They will be given a boxed lunch to eat at noon. They will return to HNRCA for blood draws at 6:00, 8:00, and 10:00 pm. They will have dinner at HNRCA after the 6:00 pm blood draw. They finish the study after the final blood draw. Participants who receive the higher dose of vitamin D, 50,800 IU, will be asked not to take more than 400 IU of vitamin D or 1000 mg per day of supplemental calcium or attend tanning salons for the month after completing the study, in order to minimize any risk of symptoms from the vitamin D. Blood draws include screening visit 20 cc, morning visit 15 cc, and three evening blood draws of 15, 15, and 15 cc, respectively, total 80 cc.
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol
- Keywords
- vitamin D, vitamin D absorption, vitamin D deficiency
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
Also called vitamin D3
800 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose
cholecalciferolDietary supplement
Also called vitamin D3
50,000 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose
cholecalciferolDietary supplement
Also called vitamin D3
50,000 IU vitamin D3, 1 dose; 800 IU vitamin D3, 1 dose
cholecalciferolDietary supplement
Also called vitamin D3
50,000 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| High MUFA/PUFA, 1600 IU vitamin D3 | Active comparator | Subjects will receive 3 meals (1 day) with a high MUFA/PUFA ratio (20g/5g), along with 800 IU of vitamin D3 and 800 IU of deuterated vitamin D3 Receives: Dietary Supplement: cholecalciferol |
| High MUFA/PUFA, 50,800 IU vitamin D3 | Active comparator | Subjects will receive 3 meals (1 day) with a high MUFA/PUFA ratio (20g/5g), along with 50,000 IU of vitamin D3 and 800 IU of deuterated vitamin D3 Receives: Dietary Supplement: cholecalciferol |
| Low MUFA/PUFA, 50,800 IU vitamin D3 | Active comparator | Subjects will receive 3 meals (1 day) with a low MUFA/PUFA ratio (5g/20g), along with 50,000 IU of vitamin D3 and 800 IU of deuterated vitamin D3 Receives: Dietary Supplement: cholecalciferol |
| Fat free meal, 50,800 IU vitamin D3 | Active comparator | Subjects will receive 3 fat-free meals (1 day) and 50,000 IU vitamin D3 and 800 IU of deuterated vitamin D3 Receives: Dietary Supplement: cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of vitamin D3 absorption after consuming meals with 3 different ratios of MUFA/PUFA content.
Measured: 10, 12 and 14 hours
Secondary outcomes (1)
The association between changes in plasma D3 and fatty acid profiles, specifically MUFAs.
Measured: 10, 12 and 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bess Dawson-Hughes, M.D., Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508845
- Sponsor's protocol ID
- 2730
- Acronym
- MUFA/PUFA
- Status last verified
- Jul 2014
- First submitted
- 9 Jan 2012
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption
- ClinicalTrials.gov ID
- NCT01508845
- Acronym / sponsor ID
- MUFA/PUFA / 2730
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, vitamin D absorption, vitamin D deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs. poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken after that meal. The study hypothesis is that vitamin D3 absorption will be greater when fat is present vs. absent in the meal. A secondary hypothesis is that vitamin D3 absorption will be greater in the presence of a meal with a high MUFA/PUFA compared with a low MUFA/PUFA ratio.
Detailed description
There is evidence that vitamin D has a favorable effect on bone and muscle. Many adults have low blood levels of 25-hydroxyvitamin D (25OHD) and consequently, vitamin D supplements are being widely recommended. The effect of a meal on the absorption of vitamin D is poorly understood. This single blind study will examine whether the amount and type of fat in the meal with which vitamin D is taken influences its absorption. Vitamin D dissolves in fat and so dietary fat may affect its absorption; moreover the type of fat with respect to mono- and poly-unsaturation may also influence absorption. This study should increase our understanding of how best to take vitamin D in order to achieve maximal absorption. Up to 65 healthy older men and women with 25OHDlevels in the insufficient range will be enrolled in order to get 60 completers in this 1-day study. They will randomized to one of three meal groups: high MUFA/PUFA (n=30), low MUFA/PUFA (n=15), or fat-free (n=15). Those in the high MUFA/PUFA group will also be randomized to a single dose of either 1,600 or 50,800 IU of vitamin D. All participants in the other two groups will receive the 50,800 IU dose. They will consume only the three meals provided during the study day. In the morning they will come to the Center for a blood draw, to consume their breakfast meal, and to take their assigned dose of vitamin D (part of which is labeled with the non-radioactive tracer, deuterium to enable direct assessment of vitamin D absorption). They will also complete questionnaires about their diet and health and have a DXA total body scan. They will be given a boxed lunch to eat at noon. They will return to HNRCA for blood draws at 6:00, 8:00, and 10:00 pm. They will have dinner at HNRCA after the 6:00 pm blood draw. They finish the study after the final blood draw. Participants who receive the higher dose of vitamin D, 50,800 IU, will be asked not to take more than 400 IU of vitamin D or 1000 mg per day of supplemental calcium or attend tanning salons for the month after completing the study, in order to minimize any risk of symptoms from the vitamin D. Blood draws include screening visit 20 cc, morning visit 15 cc, and three evening blood draws of 15, 15, and 15 cc, respectively, total 80 cc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High MUFA/PUFA, 1600 IU vitamin D3 | Active comparator | Dietary Supplement: cholecalciferolSubjects will receive 3 meals (1 day) with a high MUFA/PUFA ratio (20g/5g), along with 800 IU of vitamin D3 and 800 IU of deuterated vitamin D3 |
| High MUFA/PUFA, 50,800 IU vitamin D3 | Active comparator | Dietary Supplement: cholecalciferolSubjects will receive 3 meals (1 day) with a high MUFA/PUFA ratio (20g/5g), along with 50,000 IU of vitamin D3 and 800 IU of deuterated vitamin D3 |
| Low MUFA/PUFA, 50,800 IU vitamin D3 | Active comparator | Dietary Supplement: cholecalciferolSubjects will receive 3 meals (1 day) with a low MUFA/PUFA ratio (5g/20g), along with 50,000 IU of vitamin D3 and 800 IU of deuterated vitamin D3 |
| Fat free meal, 50,800 IU vitamin D3 | Active comparator | Dietary Supplement: cholecalciferolSubjects will receive 3 fat-free meals (1 day) and 50,000 IU vitamin D3 and 800 IU of deuterated vitamin D3 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Caucasian men and women age 50 years and older
- Women must be at least 1 year since last menses
- Subjects must agree not to attend a tanning salon or increase their sun exposure between the screening and final study visits and, for those in the higher vitamin D dose group (50,800 IU), for one month after they have completed the study.
- Subjects must agree not to take more than 400 IU of vitamin D (the amount in most multivitamins) or 1000 mg of calcium per day as their own supplements between the screening and final study visits and, for those in the higher vitamin D dose group (50,800 IU), for one month after completing the study (Note: no supplemental calcium or vitamin D is allowed on the study day.
- Screening serum 25OHD of 25 to 29.5 ng/ml
Key exclusion criteria (20 listed)
- Uncontrolled type 2 diabetes with fasting blood sugar >140 mg/dl
- GFR < 30 ml/min calculated from serum creatinine with use of the Modification of Diet in Renal Disease (MDRD) Study equation [7]
- Screening fasting spot urinary calcium:creatinine ratio (Ca:Cr) > 0.325 (corresponding to a 24-hr urine calcium of 350 mg)
- Screening serum calcium exceeding upper normal limit (reference range 8.3 -10.2 mg/dl)
- Other abnormalities in screening labs, at the discretion of the study physician (PI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferolAlso: vitamin D3800 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose | Dietary supplement | High MUFA/PUFA, 1600 IU vitamin D3 |
| cholecalciferolAlso: vitamin D350,000 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose | Dietary supplement | High MUFA/PUFA, 50,800 IU vitamin D3 |
| cholecalciferolAlso: vitamin D350,000 IU vitamin D3, 1 dose; 800 IU vitamin D3, 1 dose | Dietary supplement | Low MUFA/PUFA, 50,800 IU vitamin D3 |
| cholecalciferolAlso: vitamin D350,000 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose | Dietary supplement | Fat free meal, 50,800 IU vitamin D3 |
Primary outcome
The rate of vitamin D3 absorption after consuming meals with 3 different ratios of MUFA/PUFA content.
Time frame: 10, 12 and 14 hours
1 secondary outcome
The association between changes in plasma D3 and fatty acid profiles, specifically MUFAs.
Time frame: 10, 12 and 14 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bess Dawson-Hughes, M.D. principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol in people with Vitamin D Deficiency, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of vitamin D3 absorption after consuming meals with 3 different ratios of MUFA/PUFA content. (time frame: 10, 12 and 14 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.