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NCT01240265 · ClinicalTrials.gov registry record · Phase 2
Vitamin D Supplementation in Breastfeeding Women
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT01240265: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT01240265 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240265, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.
Interventions
- DIETARY_SUPPLEMENT Vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01240265
The ClinicalTrials.gov registry entry for NCT01240265 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 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 1 intervention - of which Vitamin D3 is the first listed.
NCT01240265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01240265 about?
NCT01240265 is a clinical study titled "Vitamin D Supplementation in Breastfeeding Women". Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplem...
What is the current status of trial NCT01240265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2010-12. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01240265?
The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01240265?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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