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Vitamin K2 and Muscle Weakness in Type 2 Diabetes
Plain-language guide to NCT05375630: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 150 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05375630
- Phase
- not phased
- Status
- status unknown
- Start
- 2022-03-21
- Completion (planned or actual)
- 2024-10
- Participants
- 150 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Diabete Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Vitamin D, K2, Magnesium and Zinc.
It had two arms (groups): Placebo (placebo comparator) and Vitamin K2 (active comparator).
The registry classes the interventions as dietary supplement.
Who Took Part
150 planned participants were the target.
It was open to people of any sex aged from 40 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age \>/= 40 years. No changes in anti-diabetic medication in the last 3 months. Muscle weakness (grip strength \<27kg and females \<16kg).
The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: BMI of 45 or higher; BP of 160/100mmHg or higher; cancer or cancer that has been in remission \<5 years.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.
The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2022-03-21 with completion listed for 2024-10.
It ran at 1 site in Kuwait.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Grip Strength (time frame: Baseline to one year).
It also tracked 9 secondary outcomes, for example SPPB, HbA1c, Blood Pressure, Body Mass, Lean Mass and Body Fat.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 150 people.
Its status is unknown; 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.