Methods |
Study design: randomised double‐blind controlled trial with 2 arms
Unit of allocation: individual
Time period of recruitment and data collection: Thailand: October 2008‐June 2013
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Participants |
Description: pregnant women in the first trimester
Location/setting: Ramathibodi Hospital of Mahidol University in Bangkok, Thailand
How participants were recruited and selected: recruited among those who registered at the Ramathibodi Hospital
Inclusion criteria: singleton pregnancy, 18‐40 years of age, gestational age ≤ 14 weeks, non‐lactating, generally healthy (no history of thyroid disorders), and not taking any iodine supplement
Exclusion criteria: TSH > 6.0 mIU/L at screening
Sample size: 511 women enrolled and randomised in Thailand
Age: not reported
Socioeconomic status: not reported
Nutritional status: 4% obese and 10%‐13% overweight
Baseline iodine status of participants/area: described by authors as mild deficiency (UIC 110‐112 µg/L)
Baseline coverage of iodized salt: 88%‐89% purchased iodized salt for the household
Breastfeeding practices: not reported
Other important information about participants or setting: at baseline, 40% (placebo group) and 47% (iodine group) were uniparous, 4.7% has subclinical hyperthyroidism and 8.6% had subclinical hypothyroidism
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Interventions |
Experimental intervention: oral iodine supplementation
Total number randomised: n = 262
Timing: starting in the first trimester
Form: oral iodine tablets
Frequency and duration: daily until delivery
Iodine compound: potassium iodide
Iodine dose: 200 µg elemental iodine
Other nutrients: see co‐interventions below
Adherence: not reported (assessed by counting the tablets returned after delivery; good compliance was defined as taking 80% of prescribed treatment)
Control/comparison intervention: placebo
Co‐intervention(s): multiple vitamin‐mineral tablets without iodine, also until delivery |
Outcomes |
Pregnancy: thyroid function (TSH, free and total T4 and T3, Tg, thyroid antibodies), UIC and thyroid gland volume in the 2nd and 3rd trimester
Postpartum: thyroid function, UIC and thyroid gland volume 6 weeks postpartum
Infant/child: birth characteristics (from hospital records) and thyroid gland volume at delivery and 6 weeks of age, thyroid function (TSH only?) at delivery from cord blood, spot UIC at 6 weeks of age, Neonatal behavioural assessment scales at 6 weeks of age (Table 8)
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
“women were allocated to two treatment groups by simple randomisation.” |
Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment method was not clear |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Subjects, caregivers and investigators were blinded |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome assessors were blinded |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Loss to follow‐up was 19%‐20% at the first follow‐up visit (second trimester) and > 20% for all subsequent visits, with 58%‐59% having 6 weeks' postpartum data (though loss was balanced between the groups and for similar reasons) |
Selective reporting (reporting bias) |
Unclear risk |
Unclear. More data were collected (through 24 months of age and in India) but to date only this PhD thesis has been published |
Other bias |
Unclear risk |
Appears to be free of other sources of bias |