← Human Trials & Peer-Reviewed Studies
Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients
Plain-language guide to NCT01675206: phase 3 randomized trial of Vitamin D, K2, Magnesium and Zinc, 165 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01675206
- Phase
- phase 3
- Status
- completed
- Start
- 2011-05
- Completion (planned or actual)
- 2011-09
- Participants
- 165 (actual)
- Design
- randomized, single-blind, prevention
- Conditions studied
- Vascular Calcification
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Vitamin D, K2, Magnesium and Zinc.
It had three arms (groups): one (active comparator), one (active comparator) and one (active comparator).
The registry classes the interventions as dietary supplement.
More on the Plan
During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al.
Thromb Haemost 2008; 100: 593-603).
MGP is a Vitamin K dependent protein.
This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form.
Who Took Part
Enrollment: 165 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age ≥18 year. Signed informed consent. End stage renal disease treated with chronic hemodialysis at least three times a week.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: coumarin treatment; known intestinal malabsorption; inability to take oral medication.
How the Study Was Run
The set-up was randomized, parallel-group and single-blind.
The participants were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.
The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.
Only one side, usually the participants, was kept unaware of whether Vitamin D, K2, Magnesium and Zinc was given.
Those kept unaware of assignments: participant.
It started in 2011-05 with completion listed for 2011-09.
Its stated primary purpose is prevention.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Vitamin D, K2, Magnesium and Zinc in 165 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.
Our Notes on the Compound
Vitamin D, K2, Magnesium and Zinc: Magnesium is described as required for AMPK to function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.