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Urine IodineNCT03845777

Urine Iodine Levels of Surgical Staff

An observational study of Urine Iodine, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: The routine use of topical iodinated antiseptic could be a possible cause of iodine contamination. The aim of this study is to evaluate iodine concentrations in operation-room staff who routinely use iodine-containing antiseptics for cleansing of the hands after salt iodization. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Urine Iodine
What is being tested?
Using Antiseptic solution
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2017to 30 Nov 2018
How long will I take part?
4 Months
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The surgical staff used iodine-containing hand scrub solutions for antisepsis

Who may be able to join

  • Surgical staff

Who cannot join

  • goiter
  • hypertension
  • thyroidectomy history

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University

    Istanbul, 34452

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Iodine-containing Antiseptics on Urine Iodine Levels of Surgical Staff

Objective: The routine use of topical iodinated antiseptic could be a possible cause of iodine contamination. The aim of this study is to evaluate iodine concentrations in operation-room staff who routinely use iodine-containing antiseptics for cleansing of the hands after salt iodization.

Methods: The study included 40 surgeons and surgical nurses who use surgical hand-scrub solutions. Participants applied an iodized brush for a minimum of three times a day on weekdays and were iodine-free on the weekends. Morning spot urine specimens were collected from all participants to analyze the urinary iodine concentration (UIC) twice a week.

Read the detailed description

Iodine is a major component of thyroid hormones. The recommended dietary allowance for adults is 150 µg per day. Measurement of the urinary iodine concentration (UIC) has been recommended to evaluate the daily nutritional intake of iodine.

According to the 2007 guidelines of the World Health Organization (WHO), the median UIC should be in the range of 100-199 µg/L for adequate daily iodine intake. Before iodization, the use of iodinated antiseptics by operating room staff provided only adequate iodine levels (125 μg/L) and did not lead to toxic doses. When iodization of table salt became mandatory in Turkey in 1998, the median UIC increased to 87 μg/L in 2001, 117 μg/L in 2004, and 130 μg/L in 2007, suggesting sufficient median iodine intake in the general population of Turkey.

In a previous study, the median UIC reached 167 μg/L at least 13 years after iodization, which suggested that iodine prophylaxis is sufficient in Istanbul. However, as a result of the widespread use of amiodarone and iodinated radiological contrast agents in clinical practice, humans are exposed to high doses of exogenous iodine. Furthermore, most surgical hand-scrub solutions contain large amounts of iodine, and transcutaneous and mucosal absorption of iodine from these solutions has been demonstrated. Therefore, the routine use of topical iodinated antiseptic could be a possible cause of iodine contamination after iodization. However, the results of iodine absorption from topical iodine-containing antiseptics are contradictory in several studies. The aim of this study is to reevaluate iodine concentrations in operation-room staff who routinely used iodine-containing antiseptics for cleansing of the hands after a long period of iodization.

MATERIALS AND METHODS This study was carried out between November 2017 and February 2018 with the operating-room staff of Istanbul University Faculty of Medicine. The study included 40 surgeons and surgical nurses who routinely use iodine-containing surgical hand brushes (Surgical Hand Brush Impregnated with 7.5% povidone-iodine). Participants applied the iodized brush for a minimum of three times a day for 3-5 minutes. The exclusion criteria were the use of intravenous iodinated contrast, the use of iodized medications, the use of thyroid hormone replacement, and salt restrictions. The study protocol was approved by the University Hospital Ethics Committee for Human Studies (No: 2017/1127). All volunteer participants provided written informed consent. The subjects used iodine-containing hand scrub solutions on weekdays and were iodine-free on the weekends. Early-morning spot urine specimens were collected from all participants to analyze the UIC twice a week: once at the beginning of the working period (the washout period of the antiseptic) and once at the end of the working period (the antiseptic exposure period). Urine samples were collected in deionized test tubes with tight lids and were immediately transported to the laboratory, acidified, and stored at -80 ºC until analysis.

UICs were determined using the Modified Microplate Method for the Determination of Urinary Iodine Concentration recommended by the CDC's Ensuring the Quality of Urinary Iodine Procedures (EQUIP) booklet with minor modifications as described by Tang et al (CDC, 2011), (Tang et al, 2015). Briefly, urine samples were dissolved at room temperature and incubated with ammonium persulfate (0.9 M final concentration) at 95 ºC on a thermal cycler for 30 minutes. After cooling, 50 µl of digested urine samples were pipetted into microplate wells. 100 µl of 0.05 M arsenious acid solution was added to each well and mixed. Finally, 50 µl of 0.019 M ceric ammonium sulfate solution was added to each well. After incubation for 30 minutes at 25 °C, absorbance at 405 nm was recorded. UICs were determined using a standard curve and expressed in μg/l.

For internal quality control analysis, urine pools (high level: 350 μg/l, low level: 80 μg/l) were prepared from patient samples, portioned, and stored at -80°C. Two levels of pooled urine samples were included in each run for quality control. Between-run coefficients of variation (CV%) for urine iodine measurements were 8.65% for the low level and 11.1% for the high level. Values of 50-99 μg/L were defined as mild iodine deficiency, values of 20-49 μg/L were defined as moderate deficiency, and values < 20 μg/L were defined as severe deficiency. Values of 100-199 μg/L were defined as adequate iodine intake, values of 200-299 μg/L were defined as exceeding iodine requirements, and values ≥ 300 μg/L were defined as potentially harmful to healthy thyroid function.

Conditions
Urine Iodine
Being tested
Using Antiseptic solution
Keywords
Iodine, Surgical, Staff, Antiseptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Using Antiseptic solutionDiagnostic test

    Using of iodine including antiseptic solutions. The investigators investigate the urine iodine status of staff before and after the using of antiseptic solution

Study groups in NCT03845777
Study groupRoleWhat they receive
Surgical StaffThe surgical staff group is the only group of the study. Blood samples of the surgical staff before and after the using antiseptics solution that include iodine were analyzed.
Receives: Diagnostic Test: Using Antiseptic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urine Iodine

    The subjects used iodine-containing hand scrub solutions on weekdays and were iodine-free on the weekends. Early-morning spot urine specimens were collected from all participants to analyze the UIC twice a week: once at the beginning of the working period (the washout period of the antiseptic) and once at the end of the working period (the antiseptic exposure period).

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2019
  2. Study start1 Nov 2017
  3. Primary completion28 Feb 2018
  4. Study completion30 Nov 2018

Resources

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
Case only
Time perspective
Prospective
Enrolment
40 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03845777
Sponsor's protocol ID
Capa Iyot
Status last verified
Feb 2019
First submitted
16 Feb 2019
Last updated
20 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Erdogan MF, Tatar FA, Unluturk U, Cin N, Uysal AR. The effect of scrubbing hands with iodine-containing solutions on urinary iodine concentrations of the operating room staff. Thyroid. 2013 Mar;23(3):342-5. doi: 10.1089/thy.2012.0325.

    PubMed 23234312
  • Grasso L, Maxia PL, Bartalena L, Murtas ML, Taberlet A, Martino E. Iodine contamination in subjects admitted to a general hospital. J Endocrinol Invest. 1992 Apr;15(4):307-8. doi: 10.1007/BF03348739.

    PubMed 1512422
  • Michalaki M, Pylioti A, Loutas V, Mamali I, Markou KB. Absence of differences in urinary iodine excretion and thyroid function tests in operating room staff members using or not using iodine-containing antiseptic solutions. Thyroid. 2013 Dec;23(12):1659-60. doi: 10.1089/thy.2013.0218. Epub 2013 Aug 1. No abstract available.

    PubMed 23724900

Questions about this trial

What is this clinical trial studying?

An observational study of Urine Iodine, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).

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 3 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 20 Feb 2019. 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 Turkey (Türkiye). 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?

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?

Urine Iodine (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03845777, which also lists 3 linked publications.

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 20 Feb 2019.

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