Healthy VolunteersNCT01079923
Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation
A study testing Single High Dose Cholecalciferol and Daily Dose Cholecalciferol in people with Healthy Volunteers, run by Mayo Clinic at 1 site in United States.
Trial summary
Research has shown that Vitamin D is important in preventing rickets in children, osteomalacia in adults, certain cancers, cardiovascular disease, Type 2 Diabetes, and metabolic syndrome. Data suggests that Vitamin D deficiency is common throughout the world. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Single High Dose Cholecalciferol and Daily Dose Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 2010
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 40 years
- non-pregnant
- non-lactating
- female
- willing to participate in study with adequate compliance and follow-up
Who cannot join
- Any clinically significant underlying chronic disease states (i.e. diabetes, asthma, seizure disorders, hypo/hyperthyroidism, hypercalcemia, hypophosphatemia, other endocrine disorders, absorption disorders)
- allergy to study medication or its components
- significant travel south of the 35° North latitude in the 28-day study period
- chronic use of steroids, anti-convulsants, or barbiturates
- participation in indoor tanning practices during the 28-day study period
Trial locations and contacts
1 site in 1 country.
About this study
Research has shown that Vitamin D is important in preventing rickets in children, osteomalacia in adults, certain cancers, cardiovascular disease, Type 2 Diabetes, and metabolic syndrome. Data suggests that Vitamin D deficiency is common throughout the world. With increasing medical conditions being linked to Vitamin D deficiency, it is suggested that establishing early normal Vitamin D levels is important to long term health.
There are low quantities of maternal Vitamin D that transfer from blood into breast milk. This places nursing infants at risk of developing low Vitamin D levels, and the American Academy of Pediatrics recommends they receive 400 international units (IU) of Vitamin D daily. If nursing mothers were supplemented with oral Vitamin D, this may produce adequate total Vitamin D in the breast milk for the growing infant to consume. By taking this potential therapeutic approach, this would prevent the burden of administering an oral Vitamin D liquid supplement to an infant.
Read more
Recent laboratory technology now allows measurement of total Vitamin D (parent Vitamin D2 plus parent Vitamin D3). The main objective of this pilot study is to compare total Vitamin D levels resulting from daily Vitamin D supplementation of 5,000 international units of cholecalciferol (Vitamin D3) orally for 28 days vs. 150,000 international units of cholecalciferol orally once in healthy, non-pregnant, non-lactating female subjects aged 18 � 40. The research results will be used to help identify an optimal dosing regimen to administer to lactating mothers to hopefully deliver adequate total Vitamin D in nursing infants. This separate study will be conducted at a later date under a subsequent protocol.
Previous research has demonstrated that Vitamin D3 levels become undetectable within 14 days after adult subjects received 100,000 international units of cholecalciferol. The investigators' central hypothesis is that daily dosing of 5,000 international units of cholecalciferol orally will maintain detectable total Vitamin D levels in serum after fourteen days, compared to high-dose 150,000 international units of oral cholecalciferol once.
It is anticipated the aims of this pilot study will yield the following results. First, we, the investigators, hope to determine the resulting Vitamin D blood levels and calculate an appropriate dosing strategy for future research. Next we plan to measure the resulting 25,hydroxyvitamin D levels that correspond with these dosing regimens, since 25,hydroxyvitamin D is the major indicator of Vitamin D status in humans. Lastly, we will measure blood calcium and phosphorus levels to assure these doses of Vitamin D are tolerated by healthy female subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Single High Dose Cholecalciferol, Daily Dose Cholecalciferol
- Keywords
- healthy volunteers, healthy subjects, vitamin D, cholecalciferol, vitamin D3, total vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single High Dose CholecalciferolDietary supplement
Also called Vitamin D3
Age 18 to 40 years, non-pregnant, non-lactating, female subjects will receive cholecalciferol 150,000 international units orally once (Bio-tech Pharmacal 50,000 IU capsule, Fayetteville, AR).
Daily Dose CholecalciferolDietary supplement
Also called Vitamin D3
Age 18 to 40 years, non-pregnant, non-lactating, female subjects will receive cholecalciferol 5,000 IU capsule, Fayetteville, AR).
| Study group | Role | What they receive |
|---|---|---|
| Single High Dose Supplementation | Active comparator | Age 18 to 40 years, non-pregnant, non-lactating, female subjects . Receives: Dietary Supplement: Single High Dose Cholecalciferol |
| Daily Dose Supplementation | Active comparator | Age 18 to 40 years, non-pregnant, non-lactating, female subjects. Receives: Dietary Supplement: Daily Dose Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D pharmacokinetics
Characterize the differences in pharmacokinetics of oral Vitamin D3 between two dosing regimens within women of child-bearing age by evaluating any changes in the number of days of detectable total serum Vitamin D and area under the curve (AUC) above baseline.
Measured: 28 days
Secondary outcomes (3)
Vitamin D Supplementation Dosing Regimen
Determine a Vitamin D3 dosing regimen that produces more days of detectable total serum Vitamin D to be used in an additional study examining the quantity of maternal vitamin D that crosses into breast milk for feeding infants.
Measured: 28 days
Vitamin D Supplementation Dosing Regimen Efficacy
Assess differences in change in baseline 25-OH-D between two dosing regimens.
Measured: 28 days
Vitamin D Supplementation Safety
Monitor for any adverse effects of Vitamin D supplementation, specifically hypercalcemia and hypophosphatemia.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Bernard R Lee, PharmD, BCPS, Principal investigator, Mayo ClinicThomas D Thacher, MD, Principal investigator, Mayo ClinicMichael E Meekins, PharmD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079923
- Sponsor's protocol ID
- 09-007602
- Status last verified
- Nov 2012
- First submitted
- 2 Mar 2010
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holick MF. Vitamin D: importance in the prevention of cancers, type 1 diabetes, heart disease, and osteoporosis. Am J Clin Nutr. 2004 Mar;79(3):362-71. doi: 10.1093/ajcn/79.3.362.
PubMed 14985208Ford ES, Ajani UA, McGuire LC, Liu S. Concentrations of serum vitamin D and the metabolic syndrome among U.S. adults. Diabetes Care. 2005 May;28(5):1228-30. doi: 10.2337/diacare.28.5.1228. No abstract available.
PubMed 15855599Foss YJ. Vitamin D deficiency is the cause of common obesity. Med Hypotheses. 2009 Mar;72(3):314-21. doi: 10.1016/j.mehy.2008.10.005. Epub 2008 Dec 2.
PubMed 19054627Suskind DL. Nutritional deficiencies during normal growth. Pediatr Clin North Am. 2009 Oct;56(5):1035-53. doi: 10.1016/j.pcl.2009.07.004.
PubMed 19931062Heaney RP, Armas LA, Shary JR, Bell NH, Binkley N, Hollis BW. 25-Hydroxylation of vitamin D3: relation to circulating vitamin D3 under various input conditions. Am J Clin Nutr. 2008 Jun;87(6):1738-42. doi: 10.1093/ajcn/87.6.1738.
PubMed 18541563Hathcock JN, Shao A, Vieth R, Heaney R. Risk assessment for vitamin D. Am J Clin Nutr. 2007 Jan;85(1):6-18. doi: 10.1093/ajcn/85.1.6.
PubMed 17209171Mastaglia SR, Mautalen CA, Parisi MS, Oliveri B. Vitamin D2 dose required to rapidly increase 25OHD levels in osteoporotic women. Eur J Clin Nutr. 2006 May;60(5):681-7. doi: 10.1038/sj.ejcn.1602369.
PubMed 16391587Ilahi M, Armas LA, Heaney RP. Pharmacokinetics of a single, large dose of cholecalciferol. Am J Clin Nutr. 2008 Mar;87(3):688-91. doi: 10.1093/ajcn/87.3.688.
PubMed 18326608Heaney 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.
PubMed 12499343Thacher TD, Obadofin MO, O'Brien KO, Abrams SA. The effect of vitamin D2 and vitamin D3 on intestinal calcium absorption in Nigerian children with rickets. J Clin Endocrinol Metab. 2009 Sep;94(9):3314-21. doi: 10.1210/jc.2009-0018. Epub 2009 Jun 30.
PubMed 19567516Saadi HF, Dawodu A, Afandi B, Zayed R, Benedict S, Nagelkerke N, Hollis BW. Effect of combined maternal and infant vitamin D supplementation on vitamin D status of exclusively breastfed infants. Matern Child Nutr. 2009 Jan;5(1):25-32. doi: 10.1111/j.1740-8709.2008.00145.x.
PubMed 19161542Armas LA, Hollis BW, Heaney RP. Vitamin D2 is much less effective than vitamin D3 in humans. J Clin Endocrinol Metab. 2004 Nov;89(11):5387-91. doi: 10.1210/jc.2004-0360.
PubMed 15531486Taylor SN, Wagner CL, Hollis BW. Vitamin D supplementation during lactation to support infant and mother. J Am Coll Nutr. 2008 Dec;27(6):690-701. doi: 10.1080/07315724.2008.10719746.
PubMed 19155428
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation
- ClinicalTrials.gov ID
- NCT01079923
- Acronym / sponsor ID
- 09-007602
- Conditions
- Healthy Volunteers
- Keywords
- healthy volunteers, healthy subjects, vitamin D, cholecalciferol, vitamin D3, total vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Mar 2010 (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.
Research has shown that Vitamin D is important in preventing rickets in children, osteomalacia in adults, certain cancers, cardiovascular disease, Type 2 Diabetes, and metabolic syndrome. Data suggests that Vitamin D deficiency is common throughout the world. With increasing medical conditions being linked to Vitamin D deficiency, it is suggested that establishing early normal Vitamin D levels is important to long term health.
There are low quantities of maternal Vitamin D that transfer from blood into breast milk. This places nursing infants at risk of developing low Vitamin D levels, and the American Academy of Pediatrics recommends they receive 400 international units (IU) of Vitamin D daily. If nursing mothers were supplemented with oral Vitamin D, this may produce adequate total Vitamin D in the breast milk for the growing infant to consume. By taking this potential therapeutic approach, this would prevent the burden of administering an oral Vitamin D liquid supplement to an infant.
Recent laboratory technology now allows measurement of total Vitamin D (parent Vitamin D2 plus parent Vitamin D3). The main objective of this pilot study is to compare total Vitamin D levels resulting from daily Vitamin D supplementation of 5,000 international units of cholecalciferol (Vitamin D3) orally for 28 days vs. 150,000 international units of cholecalciferol orally once in healthy, non-pregnant, non-lactating female subjects aged 18 � 40. The research results will be used to help identify an optimal dosing regimen to administer to lactating mothers to hopefully deliver adequate total Vitamin D in nursing infants. This separate study will be conducted at a later date under a subsequent protocol.
Previous research has demonstrated that Vitamin D3 levels become undetectable within 14 days after adult subjects received 100,000 international units of cholecalciferol. The investigators' central hypothesis is that daily dosing of 5,000 international units of cholecalciferol orally will maintain detectable total Vitamin D levels in serum after fourteen days, compared to high-dose 150,000 international units of oral cholecalciferol once.
It is anticipated the aims of this pilot study will yield the following results. First, we, the investigators, hope to determine the resulting Vitamin D blood levels and calculate an appropriate dosing strategy for future research. Next we plan to measure the resulting 25,hydroxyvitamin D levels that correspond with these dosing regimens, since 25,hydroxyvitamin D is the major indicator of Vitamin D status in humans. Lastly, we will measure blood calcium and phosphorus levels to assure these doses of Vitamin D are tolerated by healthy female subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single High Dose Supplementation | Active comparator | Dietary Supplement: Single High Dose CholecalciferolAge 18 to 40 years, non-pregnant, non-lactating, female subjects . |
| Daily Dose Supplementation | Active comparator | Dietary Supplement: Daily Dose CholecalciferolAge 18 to 40 years, non-pregnant, non-lactating, female subjects. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 40 years
- non-pregnant
- non-lactating
- female
- willing to participate in study with adequate compliance and follow-up
Key exclusion criteria (5 listed)
- Any clinically significant underlying chronic disease states (i.e. diabetes, asthma, seizure disorders, hypo/hyperthyroidism, hypercalcemia, hypophosphatemia, other endocrine disorders, absorption disorders)
- allergy to study medication or its components
- significant travel south of the 35° North latitude in the 28-day study period
- chronic use of steroids, anti-convulsants, or barbiturates
- participation in indoor tanning practices during the 28-day study period
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 |
|---|---|---|
| Single High Dose CholecalciferolAlso: Vitamin D3Age 18 to 40 years, non-pregnant, non-lactating, female subjects will receive cholecalciferol 150,000 international units orally once (Bio-tech Pharmacal 50,000 IU capsule, Fayetteville, AR). | Dietary supplement | Single High Dose Supplementation |
| Daily Dose CholecalciferolAlso: Vitamin D3Age 18 to 40 years, non-pregnant, non-lactating, female subjects will receive cholecalciferol 5,000 IU capsule, Fayetteville, AR). | Dietary supplement | Daily Dose Supplementation |
Primary outcome
Vitamin D pharmacokinetics
Time frame: 28 days
Characterize the differences in pharmacokinetics of oral Vitamin D3 between two dosing regimens within women of child-bearing age by evaluating any changes in the number of days of detectable total serum Vitamin D and area under the curve (AUC) above baseline.
3 secondary outcomes
Vitamin D Supplementation Dosing Regimen
Time frame: 28 days
Vitamin D Supplementation Dosing Regimen Efficacy
Time frame: 28 days
Vitamin D Supplementation Safety
Time frame: 28 days
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 20 Nov 2012.
- Background: PubMed 14985208Holick MF. Vitamin D: importance in the prevention of cancers, type 1 diabetes, heart disease, and osteoporosis. Am J Clin Nutr. 2004 Mar;79(3):362-71. doi: 10.1093/ajcn/79.3.362.
- Background: PubMed 15855599Ford ES, Ajani UA, McGuire LC, Liu S. Concentrations of serum vitamin D and the metabolic syndrome among U.S. adults. Diabetes Care. 2005 May;28(5):1228-30. doi: 10.2337/diacare.28.5.1228. No abstract available.
- Background: PubMed 19054627Foss YJ. Vitamin D deficiency is the cause of common obesity. Med Hypotheses. 2009 Mar;72(3):314-21. doi: 10.1016/j.mehy.2008.10.005. Epub 2008 Dec 2.
- Background: PubMed 19931062Suskind DL. Nutritional deficiencies during normal growth. Pediatr Clin North Am. 2009 Oct;56(5):1035-53. doi: 10.1016/j.pcl.2009.07.004.
- Background: PubMed 18541563Heaney RP, Armas LA, Shary JR, Bell NH, Binkley N, Hollis BW. 25-Hydroxylation of vitamin D3: relation to circulating vitamin D3 under various input conditions. Am J Clin Nutr. 2008 Jun;87(6):1738-42. doi: 10.1093/ajcn/87.6.1738.
- Background: PubMed 17209171Hathcock JN, Shao A, Vieth R, Heaney R. Risk assessment for vitamin D. Am J Clin Nutr. 2007 Jan;85(1):6-18. doi: 10.1093/ajcn/85.1.6.
- Background: PubMed 16391587Mastaglia SR, Mautalen CA, Parisi MS, Oliveri B. Vitamin D2 dose required to rapidly increase 25OHD levels in osteoporotic women. Eur J Clin Nutr. 2006 May;60(5):681-7. doi: 10.1038/sj.ejcn.1602369.
- Background: PubMed 18326608Ilahi M, Armas LA, Heaney RP. Pharmacokinetics of a single, large dose of cholecalciferol. Am J Clin Nutr. 2008 Mar;87(3):688-91. doi: 10.1093/ajcn/87.3.688.
- Background: PubMed 12499343Heaney 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.
- Background: PubMed 19567516Thacher TD, Obadofin MO, O'Brien KO, Abrams SA. The effect of vitamin D2 and vitamin D3 on intestinal calcium absorption in Nigerian children with rickets. J Clin Endocrinol Metab. 2009 Sep;94(9):3314-21. doi: 10.1210/jc.2009-0018. Epub 2009 Jun 30.
- Background: PubMed 19161542Saadi HF, Dawodu A, Afandi B, Zayed R, Benedict S, Nagelkerke N, Hollis BW. Effect of combined maternal and infant vitamin D supplementation on vitamin D status of exclusively breastfed infants. Matern Child Nutr. 2009 Jan;5(1):25-32. doi: 10.1111/j.1740-8709.2008.00145.x.
- Background: PubMed 15531486Armas LA, Hollis BW, Heaney RP. Vitamin D2 is much less effective than vitamin D3 in humans. J Clin Endocrinol Metab. 2004 Nov;89(11):5387-91. doi: 10.1210/jc.2004-0360.
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Screening Protocol
Pain
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.
Bernard R Lee, PharmD, BCPS principal investigator
Mayo Clinic
Thomas D Thacher, MD principal investigator
Mayo Clinic
Michael E Meekins, PharmD study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single High Dose Cholecalciferol and Daily Dose Cholecalciferol in people with Healthy Volunteers, run by Mayo Clinic 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 5 inclusion and 5 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 20 Nov 2012. 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?
Vitamin D pharmacokinetics (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079923, which also lists 13 linked publications.
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 20 Nov 2012.