Iodine Supplementation in Pregnant Women Living in Mild-to-moderately Iodine Deficient Areas in India and Thailand: Effects on Pregnancy Outcome and Infant Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 829
- 试验地点
- 2
- 主要终点
- Current primary outcome: Infant cognitive and motor development
研究概览
简要总结
Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine deficiency on neuromotor development are well established: randomized controlled trials of iodine supplements given to iodine deficient mothers before pregnancy or during early pregnancy improve motor and cognitive performance of their offspring. However, the potential adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear. Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in iodine deficiency.
Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid function, pregnancy outcome, birth weight, infant growth and cognitive performance.
Study design: Double-blind randomized controlled multicentre trial. Study population: Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be recruited at two research sites, namely St. Martha's hospital in Bangalore, India and Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be recruited.
Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and the other half to placebo throughout pregnancy.
Main study parameters/endpoints: Differences between group means in indicators of thyroid function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years;
- •Gestational age: ≤ 14 weeks (as judged by the date of the last menstrual period);
- •Single pregnancy;
- •Non-lactating;
- •Planned residence in the area for the duration of the study (3 years).
排除标准
- •TSH levels outside the normal range
- •History of serious medical conditions such as HIV, hypertension, diabetes, renal, hepatic or cardiovascular disease, thyroid disorders, mental disorders;
- •Use of iodine supplement.
研究组 & 干预措施
1
干预措施: Iodine (Dietary Supplement)
2
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Current primary outcome: Infant cognitive and motor development
时间窗: Regular intervals up till 6 years of age
Original primary outcome: Maternal thyroid function
时间窗: 3-month intervals during pregnancy, at delivery
次要结局
- Long-term follow up(Child age 2-6 years)
- Breast milk iodine(3 and 6 months after delivery)
- Birth outcome(At delivery)
- Maternal and infant urinary iodine(Regular intervals during pregnancy up till 2 years after delivery)