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NCT01079923 · ClinicalTrials.gov registry record · NA
Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01079923: Completed NA study, sponsored by Mayo Clinic.
NCT01079923 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01079923, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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. 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 oral
Interventions
- DIETARY_SUPPLEMENT Single High Dose Cholecalciferol
- DIETARY_SUPPLEMENT Daily Dose Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01079923
The ClinicalTrials.gov registry entry for NCT01079923 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Single High Dose Cholecalciferol is the first listed.
NCT01079923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01079923 about?
NCT01079923 is a clinical study titled "Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation". 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...
What is the current status of trial NCT01079923?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2010-02. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01079923?
The interventions under investigation include: Single High Dose Cholecalciferol (DIETARY_SUPPLEMENT), Daily Dose Cholecalciferol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01079923?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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