Maternal Docosa-Hexaenoic Acid (DHA) Supplementation and Offspring Neurodevelopment in India (DHANI-2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 957
- 试验地点
- 1
- 主要终点
- Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age
研究概览
简要总结
DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.
详细描述
A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. The mother-child dyads would be followed through infant age 1 year and anthropometric measurements and biochemical investigations would be used to assess the effect of maternal DHA supplementation on infant neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale for Indian Infants (DASII).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing, healthy singleton gestation of ≤ 20 weeks (scan report must)
- •18-35 years
- •Hb > 7 g/dL
- •Non-fasting glucose as per Diabetes in Pregnancy Study Group of India (DIPSI) criteria (<140mg/dL)
- •No history of chronic diseases (heart disease, diabetes, liver disorders, cancer, epilepsy, HIV, thyroid) or
- •High risk pregnancy (short stature**, molar pregnancy++, HBsAg positive, as advised by physicians)
- •<143 cm ++ A molar pregnancy starts when an egg is fertilized, but instead of a normal, viable pregnancy resulting, the placenta develops into an abnormal mass of cysts.
排除标准
- •Women allergic (if aware) to any of the test products.
- •Women at high risk for hemorrhagic bleeding, clotting (if aware).
- •Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
- •Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
- •Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).
研究组 & 干预措施
Docosa Hexaenoic Acid (DHA)
Omega 3 Fatty Acid
干预措施: Docosa Hexaenoic Acid (DHA) (Dietary Supplement)
Placebo
Corn/Soy Oil
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age
时间窗: 12 months (± 4 weeks)
The development quotient (DQ) among infants at 12 months of age assessed using the standardized Development Assessment Scale for Indian Infants (DASII). DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. DASII provides a measure of DQ among Indian infants below 30 months of age. DQ is defined as the ratio of functional to chronological age. Third, 50th and 97th percentile norms are given. A higher score indicates a better outcome. The maximum DQ score is 100; ≥85 is normal; 71-84 is mild to moderate delay and developmental delay is defined as DQ ≤70 (≤2SD). Median reliability index for motor and mental scales based on correlation between consecutive months is noted to be 0.88 for motor scales and 0.91 for mental scales.
次要结局
- Mean difference in infant developmental quotient (DQ) at 6 month(6 months (± 4 weeks))
- Mean difference in infant motor score at 6 month(6 (± 4 weeks))
- Mean difference in infant mental score at 6 month(6 months (± 4 weeks))
- Difference in numbers / proportions of infants with developmental delay(6 months (± 4 weeks) and 12 (± 4 weeks) months)
- Mean difference in infant weight (in grams) at birth(At delivery)
- Mean difference in infant (in centimeters) at birth(At delivery)
- Mean difference in infant head circumference (in centimeters) at birth(At delivery)
- Mean difference in infant APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score at birth.(At delivery)
- Mean change in infant weight (in grams) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group(At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks))
- Mean change in infant length (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group(At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks))
- Mean change in infant head circumference (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group(At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks))
- Mean difference in proportions of still births between Docosahexaenoic acid (DHA) and placebo groups.(At delivery)
- Mean difference in proportions of preterm babies between Docosahexaenoic acid (DHA) and placebo groups.(At delivery)
- Mean difference in proportions of low birth weight babies between Docosahexaenoic acid (DHA) and placebo groups.(At delivery)
- Difference in infant morbidity patterns between Docosahexaenoic acid (DHA) and placebo groups(1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks))