Fatigue Syndrome, ChronicNCT06596161
Iron Therpay and Fatigue in Women of Reprodcutive Age
A study testing Iron sucrose in people with Fatigue Syndrome, Chronic and Fatigue, run by Central Park Medical College at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue Syndrome, Chronic, Fatigue
- What is being tested?
- Iron sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2023to 2 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- reproductive age non-anemic fatigued
Who cannot join
- anemiac males
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect or Iron Therapy on Fatigue Symptoms in Non-anemic Iron Deficient Women of Reproductive Age
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
- Conditions
- Fatigue Syndrome, Chronic, Fatigue
- Being tested
- Iron sucrose, Placebo
- Keywords
- fatigue
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron sucroseDrug
Receving iron
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Receiving Iron Receives: Drug: Iron sucrose |
| Control Group | Placebo comparator | Receiving Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Score improvemnt
improvement in fatigue levels
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Feb 2023
- Primary completion20 Feb 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Park Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596161
- Sponsor's protocol ID
- CPMC/IRB-No/1388
- Other IDs
- CPMC
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect or Iron Therapy on Fatigue Symptoms in Non-anemic Iron Deficient Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT06596161
- Acronym / sponsor ID
- CPMC/IRB-No/1388
- Conditions
- Fatigue Syndrome, Chronic, Fatigue
- Keywords
- fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Central Park Medical CollegeUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Iron sucroseReceiving Iron |
| Control Group | Placebo comparator | Drug: PlaceboReceiving Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- reproductive age non-anemic fatigued
Key exclusion criteria (1 listed)
- anemiac males
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron sucroseReceving iron | Drug | Study Group |
| PlaceboPlacebo | Drug | Control Group |
Primary outcome
Fatigue Score improvemnt
Time frame: 60 days
improvement in fatigue levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron sucrose in people with Fatigue Syndrome, Chronic and Fatigue, run by Central Park Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Score improvemnt (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.