NCT05319951

Brief Summary

we compared the effect of 3 different kinds of liquids (water, Oral Rehydration Salt 3 and white granulated sugar water) intake in Vasovagal Reaction After Whole Blood Donation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

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

December 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

December 1, 2020

Last Update Submit

September 30, 2022

Conditions

Blood Donation

Outcome Measures

Primary Outcomes (1)

  • vasovagal reaction rate

    vasovagal reaction rate in three groups

    1-3days

Secondary Outcomes (1)

  • rate of willingness to donate blood again

    3days

Study Arms (3)

Oral Rehydration Salts Power (iii)

EXPERIMENTAL

Dissolve 2 packs of Oral Rehydration Salts Power (iii) (5.125g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.

Drug: Oral Rehydration Salts power (iii)

water with white granulated sugar

EXPERIMENTAL

Dissolve 2 packs of Taikoo white granulated sugar (5g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.

Dietary Supplement: water with white granulated sugar

recommended water intake

PLACEBO COMPARATOR

Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.

Dietary Supplement: water

Interventions

Oral Rehydration Salts power (iii)DRUG

Dissolve 2 packs of Oral Rehydration Salts Power (iii) (5.125g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.

Also known as: Sichuan Emeishan Pharmaceutical Co., Ltd. 20210402 5100621103491
Oral Rehydration Salts Power (iii)
water with white granulated sugarDIETARY_SUPPLEMENT

Dissolve 2 packs of Taikoo white granulated sugar (5g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.

water with white granulated sugar
waterDIETARY_SUPPLEMENT

Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.

recommended water intake

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Blood Center

Guangzhou, Guangdong, 510095, China

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Guiyun Xie, MPH

    Guangzhou Blood Center

    STUDY CHAIR

  • Jinyan Chen, MPH

    Guangzhou Blood Center

    PRINCIPAL INVESTIGATOR

  • Shijie Li

    Guangzhou Blood Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

April 11, 2022

Study Start

January 20, 2021

Primary Completion

November 26, 2021

Study Completion

December 31, 2021

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

CN(1)