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Arabic Gum-Absorption Study
Plain-language guide to NCT00858767: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 69 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00858767
- Phase
- not phased
- Status
- completed
- Start
- 2008-10
- Completion (planned or actual)
- 2009-05
- Participants
- 69 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Bioavailability
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.
The Japanese soya product natto is one of the richest food sources of MK-7, but its taste is not appreciated by the Western society.
It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (active comparator).
The registry classes the interventions as dietary supplement.
Who Took Part
The registry lists 69 actual participants took part.
It was open to people of any sex aged from 20 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy men and women aged between 20 and 40 y. Normal body weight and height (BMI \<30 kg/m2). Stable body weight (weight gain or loss \<3 kg in past 3 mo). Written consent to take part in the study. Low vitamin K status.
The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: (A history of) metabolic or gastrointestinal diseases; chronic degenerative and/or inflammatory diseases; abuse of drugs and/or alcohol.
How the Study Was Run
Design: randomized, parallel-group and double-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.
Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.
Those kept unaware of assignments: participant and investigator.
It started in 2008-10 with completion listed for 2009-05.
It ran at 1 site in Netherlands.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: serum level menaquinone-7 (time frame: 8 weeks).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 69 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.