NCT03716609

Brief Summary

Using a double-blind randomized controlled trial design, this study intends to evaluate the short-term effect of magnesium citrate on cognitive functions and hemodynamic parameters in MCI elders, including Montreal Cognitive Assessment, working memory test-digit span test, carotid artery flow velocity, ankle-brachial blood pressure ratio, and urinary magnesium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 23, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

October 22, 2018

Last Update Submit

January 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • End-diastolic velocity

    End-diastolic velocity of internal carotid artery

    Two hours from intervention to follow-up measurement

Study Arms (2)

Magnesium supplement group

EXPERIMENTAL

Subjects receive citrate acid drinks with additional magnesium citrate (300mg magnesium)

Dietary Supplement: Magnesium CitrateOther: Food grade citrate acidOther: Splenda(Sucralose)

placebo group

PLACEBO COMPARATOR

Subjects receive citrate acid drinks without additional magnesium

Other: Food grade citrate acidOther: Splenda(Sucralose)

Interventions

Magnesium CitrateDIETARY_SUPPLEMENT

Pure Magnesium citrate powder 2.07 gram from NOW FOODS (Bloomingdale, IL, USA)

Magnesium supplement group

Food grade citrate acid 0.1 gram from San Fu Chemical Co., Ltd (Taipei, Taiwan)

Magnesium supplement groupplacebo group

Splenda 1.0 gram from Splenda(Carmel, Indiana, USA)

Magnesium supplement groupplacebo group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with mild cognitive impairment (Mini-Metal State Examination \< 26 points)
  • Participants signing the informed consent form

You may not qualify if:

  • Participants regularly taking magnesium supplements
  • Participants who had severe illness (e.g. cancer, ridden bed)
  • Participants unable to speak, with visual disorder and hearing impairment)
  • Participants hospitalized who live in elderly homes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academia Sinica

Taipei, 115, Taiwan

Location

MeSH Terms

Interventions

magnesium citrate

Study Officials

  • Wen-Harn Pan, Ph.D.

    Institute of Biomedical Sciences, Academia Sinica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Research Fellow

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 23, 2018

Study Start

October 23, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2021

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations