IODIDE I-123 SUMMARY
Sodium Iodide I-123 Capsules
Sodium Iodide I-123 (Na123I) for diagnostic use is supplied in capsules for oral administration.
Administration of Sodium Iodide I-123 is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
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NEWS HIGHLIGHTS
Clinical Trials Related to Iodide I-123
A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years [Completed]
The purpose of this trial is to determine whether iodide supplementation of neonates born
under 31 weeks gestation improves neurodevelopment measured at two years of age.
Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer [Recruiting]
This phase II trial studies how well trametinib works in increasing tumoral iodine
incorporation in patients with thyroid cancer that has come back or spread to another place
in the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and may help make treatment with iodine I-131 more effective.
Iodine Status in Swedish Lactating Women - Effect of Iodine Supplementation in the Thyroid Function of Mother and Infant [Recruiting]
The aim of the study is to measure urinary milk iodine concentration (MIC), iodine
concentration (UIC), thyroid hormones (TSH, FT4) and thyroperoxidase antibodies (TPOab) in
breast-feeding women, and UIC in their nursing infants to determine if the levels are
adequate, and to see how they can be influenced by 150 ug daily iodine supplementation in
breast-feeding women. The hypothesis is that there is a relative iodine deficiency in this
sub-population - lactating women and nursing child, and that this can be influenced by
iodine supplementation. Adequate thyroid hormone and iodine levels are very important for
small children, when the plasticity of the brain is greatest.
This is as a prospective, double-blind, placebo-controlled study of 200 mothers and their
infants. In parallel, 90 age-matched healthy non-pregnant women are recruited. Mothers are
randomized to 150 µg/day iodide supplementation or placebo.
Pregnant women are asked for participation on a visit in pregnancy week 35, at the mother
health care (MVC) at Mölnlycke and Skövde. The study will run for approximately 6 months for
each individual and begins by sampling 1 (UIC, TSH, FT4, TPOab) at week 37 of the pregnancy.
One week after birth, when the sample 2 is collected (as above inclusively MIC), women get
randomized to 150 µg iodine or placebo. New sampling 3 (UIC, TSH, FT4, MIC ) and 4 (same as
sampling 2) is collected after 3 and 6 months respectively. 6 months after birth the study
is completed for every individual. In parallel, 90 healthy non-pregnant, non-lactating women
in the same age range are recruited and followed with UIC, TSH, FT4, TPOab for 6 months as a
control group. In each case a simple questionnaire is filled and blood is also frozen for
future analyses .
Iodine Status in Swedish Pregnant Women - Effect of Iodine Supplementation in the Thyroid Function of Mother and Infant [Recruiting]
Aims
- To compare milk iodine concentration (MIC) in colostrum, urinary iodine concentration
(UIC) and TSH in the newborn child to pregnant women receiving 150 µg iodide or placebo
- To compare UIC, thyroglobulin (Tg), free tetraiodothyronine (FT4) and TSH in pregnant
mothers on 150 µg iodide or placebo Background Iodine deficiency results in
hypothyroidism and goiter and during the pregnancy increases the risk for abortion or
cognitive and other abnormalities. According to the WHO recommendations, UIC for
pregnant women should be 150-249 ug/L. A study confirmed in 2007 iodine sufficiency in
Sweden. It is debated whether or not iodide shall be given to pregnant women in iodine
sufficient populations: In Japan, the median UIC in pregnancy was 195-220 µg /L, in
Switzerland 116-166 µg /L and in US 125 µg /L. Our hypothesis is that an iodine
supplementation of 150 µg/day is needed during pregnancy in Sweden in order to ensure
normal iodine and thyroid hormone status in mothers and newborn children.
Project description This is a prospective, double-blinded placebo-controlled trial of 200
pregnant women and their children. Mothers are randomized to 150 µg/day iodide
supplementation or placebo for 26 weeks. In parallel 90 healthy female controls are
recruited from the same community stratified for age and smoking habits. Patients are
included after the first mother health care (MVC) visit by the midwife at Skövde. UIC,
U-creatinine, thyroid hormones, Thyroid stimulating hormone (TSH), Thyroglobuline (Tg) and
thyroperoxidase antibodies (TPO-ab) are collected and a simple questionnaire is filled in
week 10±2 weeks of pregnancy and placebo/iodide is started. Selenium and iron will also be
measured. The same measurements are collected in week 25±1 week and week 36±2weeks. Directly
after delivery (within 5 Days), MIC and UIC in the mother as well as UIC and TSH in the
newborn child are collected and a simple questionnaire is filled in. Weight, length and
APGAR in the child and pregnancy complications are registered. Blood is also frozen for
future analyses.
Controls are collected from a randomized sample attain by the Swedish Tax Agency of
premenopausal women from the same community stratified for age and smoking habits. UIC,
u-creatinine, FT4, TSH, Tg, TPO-ab, selenium, iron and samples to be frozen are collected
and a questionnaire is filled in. The primary purpose for having a control population is to
ascertain that the normal population in the area of Skövde is iodine sufficient.
Preventing Lack of Iodine During Pregnancy [Terminated]
The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy
on neuro-cognitive development of children followed up until two years.
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Page last updated: 2008-04-29
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