NCT06596161

Brief Summary

For the assessment of anemia and then assessment of fatigue levels in non-anemic women followed by assessment of iron levels and intervention of iron and placebo

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

September 11, 2024

Last Update Submit

September 11, 2024

Conditions

Fatigue Syndrome, ChronicFatigue

Keywords

fatigue

Outcome Measures

Primary Outcomes (1)

  • Fatigue Score improvemnt

    improvement in fatigue levels

    60 days

Study Arms (2)

Study Group

EXPERIMENTAL

Receiving Iron

Drug: Iron sucrose

Control Group

PLACEBO COMPARATOR

Receiving Placebo

Drug: Placebo

Interventions

Iron sucroseDRUG

Receving iron

Study Group
PlaceboDRUG

Placebo

Control Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales of reproductive age
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • reproductive age non-anemic fatigued

You may not qualify if:

  • anemiac males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Park Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Fatigue Syndrome, ChronicFatigue

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

February 25, 2023

Primary Completion

February 20, 2024

Study Completion

March 2, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

PA(1)