Effects of heat stress on maternal lactation performance & infant growth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Plasma oxidative stress markers in lactating mothers of 3-month-old babies.
研究概览
简要总结
This is a feasibility component of an observational study with primary objective of assessing impact of climate change on lactating performance of exclusive breastfeeding mother and infant’s anthropometric growth. As causal pathways of extreme summer impacting human health are assumed to be inflammatory and oxidative stress, this feasibility study objective is to see if Omega-3 fatty acid (OFA) supplementation can improve antioxidant level of lactating mothers to cope with extreme heat stress during summer. 50 eligible lactating mothers from observational component who will be recruited in winter, 2025 -2026 in Kalaburagi, Karnataka will be randomized into two groups. One will receive daily supplementation of 1g OFA (from algal DHA capsules) packaged in 500 mg gelatin capsules for three months, and the control group receiving a placebo (gelatin capsules with saline water) during summer 2026. It will evaluate the potential of OFA to reduce oxidative stress by improving maternal antioxidant status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Rural lactating women aged 20-35 years and their children within 0-4 months of age.
- •No major morbidities Normal healthy growing child with normal delivery, no major morbidities.
排除标准
- •1.Major chronic illness for mother or baby 2.Intention to leave the site 3.On any supplementation/medication
- •Moderate/severe anemia 5.Likely to change employment status".
结局指标
主要结局
Plasma oxidative stress markers in lactating mothers of 3-month-old babies.
时间窗: Baseline and after 90 days of intervention
Plasma oxidative stress markers arylesterase activity of paraoxanase 1 (PON-1) will be assayed.Myeloperoxidase (MPO) will be measured as the rate of oxidation of o-dianisidine .Lipid peroxidase (LPO)
时间窗: Baseline and after 90 days of intervention
will be measured as mmol thiobarbituric acid-reactive species formed on reaction of plasma.Total antioxidant (ToAx) will be measured using the TEAC method
时间窗: Baseline and after 90 days of intervention
次要结局
- "• Hemoglobin (Hb) concentration & iron status of lactating mothers.(• Anthropometric growth of the children.")
研究者
Dr Santu Ghosh
St John’s Medical College, Bangalore