Thyroid DysfunctionI2 and thyroidNCT04809454
Frequency of Florid Hyperthyroidism In Patients Taking Iodinated Salt
An observational study of Thyroid Dysfunction, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
Thyroxin a vital hormone for life lot of body functions depend on proper functioning on pituitary thyroid axis. it exists in two major forms Thyroxine (T4) and (T3) , each of them containing two iodine atoms on their inner (tyrosine) ring. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thyroid Dysfunction
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2021to Mar 2022
- Phase
- Observational
- 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 60 years
- All sexes
- Adult
Study population: All patients presenting with biochemical hyperthythyroidism and taking Iodinated salt with age range of 18-60 years
Who may be able to join
- All patients presenting with biochemical hyperthyroidism
- Who are taking Iodinated salt.
- Treatment naïve patients
- Both genders included
- All patients who can give consent (18-60 years)
Who cannot join
- 1) Pregnant females 2) Lactating mothers
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Mehwish Iftikhar
Lahore, Punjab Province, 54000
Mehwish Iftikhar, FCPS Endocrinology, 923004291641, drmehwish19@gmail.com
Amna Rizvi, FCPS Endocrinology, 923009463345, amnarizvi512@gmail.com
About this study
Official title: Frequency of Florid Hyperthyroidism In Patients Taking Iodinated Salt: A Cross Sectional Study
Thyroxin a vital hormone for life lot of body functions depend on proper functioning on pituitary thyroid axis. it exists in two major forms Thyroxine (T4) and (T3) , each of them containing two iodine atoms on their inner (tyrosine) ring. Synthesis of reasonable quantities of thyroid hormones requires adequate iodine intake to allow sufficient thyroidal uptake. The World Health Organization (WHO) recommendation for daily intake of iodine is 150 μg for children ≥12 years and adults, and 250 μg for pregnant and lactating women. However as we know optimum amount of iodine is required for normal pituitary thyroid axis like wise excessive intake may cause over functioning of axis hence over production of hormone that can be manifested both clinically and biochemically.
This study is designed to observe the frequency of over hyperthyroidism in patients taking iodinated salt.
Read the detailed description
All patients presenting to endocrine clinic fulfilling inclusion and exclusion criteria will be recruited. They will be examined, their vitals including blood pressure pulse will be noted, thyroid clinical examination including eye signs and thyroid status will be done biochemical Thyroid profile (TSH, Free T3 \& Free T4) will be noted in predesigned proforma.
Statistical Analysis will be done ,after data is entered in Statistical Package for the Social Sciences (SPSS) version 25 .qualitative data will be presented as frequencies and percentages while quantitative data will be presented as mean medians and standard deviations.
- Conditions
- Thyroid Dysfunction
- Keywords
- Thyroid, Iodine
- Medical subject headings
- Thyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect of Iodinated Salt on Thyroid Status
Affect of Iodinated Salt on Thyroid Status
Measured: through study completion an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startOct 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DysfunctionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehwish Iftikhar, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809454
- Sponsor's protocol ID
- 1241985
- Acronym
- I2 and thyroid
- Status last verified
- Sep 2021
- First submitted
- 16 Mar 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Florid Hyperthyroidism In Patients Taking Iodinated Salt: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04809454
- Acronym / sponsor ID
- I2 and thyroid / 1241985
- Conditions
- Thyroid Dysfunction
- Keywords
- Thyroid, Iodine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- Oct 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 22 Mar 2021 (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.
Thyroxin a vital hormone for life lot of body functions depend on proper functioning on pituitary thyroid axis. it exists in two major forms Thyroxine (T4) and (T3) , each of them containing two iodine atoms on their inner (tyrosine) ring. Synthesis of reasonable quantities of thyroid hormones requires adequate iodine intake to allow sufficient thyroidal uptake. The World Health Organization (WHO) recommendation for daily intake of iodine is 150 μg for children ≥12 years and adults, and 250 μg for pregnant and lactating women. However as we know optimum amount of iodine is required for normal pituitary thyroid axis like wise excessive intake may cause over functioning of axis hence over production of hormone that can be manifested both clinically and biochemically.
This study is designed to observe the frequency of over hyperthyroidism in patients taking iodinated salt.
Detailed description
All patients presenting to endocrine clinic fulfilling inclusion and exclusion criteria will be recruited. They will be examined, their vitals including blood pressure pulse will be noted, thyroid clinical examination including eye signs and thyroid status will be done biochemical Thyroid profile (TSH, Free T3 \& Free T4) will be noted in predesigned proforma.
Statistical Analysis will be done ,after data is entered in Statistical Package for the Social Sciences (SPSS) version 25 .qualitative data will be presented as frequencies and percentages while quantitative data will be presented as mean medians and standard deviations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- All patients presenting with biochemical hyperthythyroidism and taking Iodinated salt with age range of 18-60 years
Key inclusion criteria (5 listed)
- All patients presenting with biochemical hyperthyroidism
- Who are taking Iodinated salt.
- Treatment naïve patients
- Both genders included
- All patients who can give consent (18-60 years)
Key exclusion criteria (2 listed)
- 1) Pregnant females 2) Lactating mothers
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Affect of Iodinated Salt on Thyroid Status
Time frame: through study completion an average of 12 weeks
Affect of Iodinated Salt on Thyroid Status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Dysfunction, run by Services Institute of Medical Sciences, Pakistan 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehwish Iftikhar, FCPS Endocrinologyy (923004291641, drmehwish19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affect of Iodinated Salt on Thyroid Status (time frame: through study completion an average of 12 weeks). 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 22 Sep 2021.