A randomized control trial to understand the effect of novel nutrients for maternal, newborn, and child health in the rural community in India
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Primary outcomes
研究概览
简要总结
The aim of the study is to understand the effect of antenatal supplementation with novel micronutrients - nicotinamide, choline, and DHA (docosohexanoic acid) on pregnancy and birth outcomes, as well as infant neurocognitive development in India. This will be a placebo-controlled randomized trial with two arms: the intervention arm will receive standard care, nutrition advice, Zincovit, and doses of nicotinamide (100 mg), choline (450 mg), and DHA (200 mg), while the control arm will receive standard care, nutrition advice, Zincovit, and a placebo. Standard care includes iron, folic acid, and calcium supplementation commonly followed in antenatal care. The study will recruit pregnant women aged 18-45 years who provide written informed consent at KV Kuppam block. It will focus on primary outcomes such as newborn outcomes, pregnancy outcomes, and childhood growth and development during the first two years of life along with childhood brain development assessed through hyperfine MRI imaging. Secondary outcomes will explore the relationship between biochemical micronutrient and anemia status with childhood growth, development and brain morphometry, prevalence of iron deficiency and micronutrient deficiency anemia during pregnancy and early childhood, and investigate the impact of novel micronutrients on improving anemia in mothers and young children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women with confirmed pregnancy with gestational age less than 14 weeks
- •Living in the recruitment geographical area and willing to spend the whole pregnancy in the area for the main study and 2-year postpartum for the sub-study
- •Singleton and viable fetus on ultrasound.
排除标准
- •Pregnant women with any known medical co-morbidities in the pre-pregnancy period (DM, HTN, Thyroid, SLE, etc) 2) Multipara with bad obstetric history 3) Any known food allergies.
结局指标
主要结局
Primary outcomes
时间窗: 1. Newborn outcomes - birth/newborn period | 2. Pregnancy outcomes - pregnancy monthly follow-up, birth | 3. Birth weight -birth | 4. Child growth | Monthly follow-ups till 24 months | Child development -6,12,18 and 24 months | Hyperfine neuroimaging - 6, 12 and 24 months
1. Effect on newborn outcomes - compound and individual outcomes (% low birth weight, % preterm, % small for gestation age, neonatal mortality, neonatal significant morbidity)
时间窗: 1. Newborn outcomes - birth/newborn period | 2. Pregnancy outcomes - pregnancy monthly follow-up, birth | 3. Birth weight -birth | 4. Child growth | Monthly follow-ups till 24 months | Child development -6,12,18 and 24 months | Hyperfine neuroimaging - 6, 12 and 24 months
2. Effect on pregnancy outcomes - compound and individual pregnancy outcomes (loss, preterm, maternal morbidity, mortality)
时间窗: 1. Newborn outcomes - birth/newborn period | 2. Pregnancy outcomes - pregnancy monthly follow-up, birth | 3. Birth weight -birth | 4. Child growth | Monthly follow-ups till 24 months | Child development -6,12,18 and 24 months | Hyperfine neuroimaging - 6, 12 and 24 months
3. Effect on birth weight
时间窗: 1. Newborn outcomes - birth/newborn period | 2. Pregnancy outcomes - pregnancy monthly follow-up, birth | 3. Birth weight -birth | 4. Child growth | Monthly follow-ups till 24 months | Child development -6,12,18 and 24 months | Hyperfine neuroimaging - 6, 12 and 24 months
4. Childhood growth and development
时间窗: 1. Newborn outcomes - birth/newborn period | 2. Pregnancy outcomes - pregnancy monthly follow-up, birth | 3. Birth weight -birth | 4. Child growth | Monthly follow-ups till 24 months | Child development -6,12,18 and 24 months | Hyperfine neuroimaging - 6, 12 and 24 months
次要结局
- Secondary Outcome/s:(1. Relationship between biochemical micronutrient & anemia status with childhood growth, development & brain morphometry.)
研究者
Dr Beena Koshy
Christian Medical College, Vellore