Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01079923
First received: March 2, 2010
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Healthy Volunteers
Dietary Supplement: Single High Dose Cholecalciferol
Dietary Supplement: Daily Dose Cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Vitamin D pharmacokinetics [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Vitamin D Supplementation Dosing Regimen [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.

  • Vitamin D Supplementation Dosing Regimen Efficacy [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Assess differences in change in baseline 25-OH-D between two dosing regimens.

  • Vitamin D Supplementation Safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Monitor for any adverse effects of Vitamin D supplementation, specifically hypercalcemia and hypophosphatemia.


Enrollment: 40
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single High Dose Supplementation
Age 18 to 40 years, non-pregnant, non-lactating, female subjects .
Dietary Supplement: Single High Dose Cholecalciferol
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).
Other Name: Vitamin D3
Active Comparator: Daily Dose Supplementation
Age 18 to 40 years, non-pregnant, non-lactating, female subjects.
Dietary Supplement: Daily Dose Cholecalciferol
Age 18 to 40 years, non-pregnant, non-lactating, female subjects will receive cholecalciferol 5,000 IU capsule, Fayetteville, AR).
Other Name: Vitamin D3

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 to 40 years
  • non-pregnant
  • non-lactating
  • female
  • willing to participate in study with adequate compliance and follow-up

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079923

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Bernard R Lee, PharmD, BCPS Mayo Clinic
Principal Investigator: Thomas D Thacher, MD Mayo Clinic
Study Director: Michael E Meekins, PharmD Mayo Clinic
  More Information

Publications:

Responsible Party: Bernard Lee, PharmD, BCPS, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01079923     History of Changes
Other Study ID Numbers: 09-007602
Study First Received: March 2, 2010
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
healthy volunteers
healthy subjects
vitamin D
cholecalciferol
vitamin D3
total vitamin D

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014