Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- BMIC
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency.
The main questions it aims to answer are:
- What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials?
- What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status?
- How do iodine and iron interact with each other to affect thyroid function in the mother during lactation?
Participants will be randomized to receive a daily multiple micronutrient tablet containing iodine (UNIMAPP) for 6 months postpartum, or routine postnatal care per Ethiopia Ministry of Health. Mothers will provide a breast milk sample and blood at 3 and 6 months postpartum. Infants will provide a urine sample and drop of blood, and have a neurodevelopmental assessment at 3 and 6 months.
Researchers will compare the groups that received the iodine-containing micronutrient supplement with the group that received routine care and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be eligible, women will be required to meet the following inclusion criteria:
- •Maternal age 18 years or above, singleton pregnancy,
- •data available on Last Menstrual Period (LMP) or early ultrasound,
- •Intention to exclusively feed breastmilk for 4 to 6 months,
- •Intention to stay in the study catchment area for at least 6 months,
- •Willingness to take a daily supplement of MMS for 6 months
排除标准
- •Severe maternal morbidity (postpartum eclampsia, postpartum hemorrhage),
- •Maternal condition leading to inability for infant to directly/exclusively breastfeed (maternal mastectomy, or other breast surgery),
- •Breast cancer,
- •Tuberculosis
研究组 & 干预措施
Iodine Containing Multiple Micronutrient (UNIMMAP)
UNIMMAP 1 tablet po once daily from birth to 6 months postpartum
干预措施: UNIMMAP Multiple Micronutrient Supplement (Dietary Supplement)
Routine postnatal care
Routine postnatal care per Ethiopian Ministry of Health guidelines
结局指标
主要结局
BMIC
时间窗: 1 month post partum
Breast Milk Iodine Concentration at 1 month
Visual Evoked Potentials
时间窗: 6 months post partum
P1 Latency
次要结局
- Infant Tg(6 months)
- Infant TSH(6 months)
- EEG Fc(6 months)
- Infant HCAZ at 6 months(6 months)
- Infant UIC(6 months)
研究者
Anne Shee CC Lee
Levinger Family Professor of Pediatrics
Brown University