Effect of Energy Dense Biscuits in Under Nourished Pregnant Women on Birth Weight of Their Newborns in a Low Income Peri-urban Setting of Karachi; a Community Based Randomized Interventional Study
试验速览
- 阶段
- 不适用
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Neonatal birth weight
研究概览
简要总结
A nutrition trial which is based on the evidence that multivitamins & micro nutrients provided during pregnancy in malnourished women will improve neonatal birth weight. There will be two arms. Arm one will provide energy dense biscuits to pregnant women with BMI <20 & gestational age less than 14 weeks. The other arm with same criteria will be provided with wheat flour, oil, iron & folic acid. Neonatal birth weight is the primary outcome of interest but maternal weight gain, maternal hemoglobin & ferritin levels and palatability of biscuits will also be assessed.
详细描述
It has been realized that micronutrient deficiencies are a major determinant of intra-uterine growth retardation (IUGR) so multiple trials using micronutrient supplementation during pregnancy have been done & shown a positive effect on birth weight.UNICEF/WHO/United Nations University(UNU) designed a new multiple micro nutrient supplement for pregnant and lactating women-the UNICEF/WHO/UNU international multiple micro nutrient preparation (UNIMMAP)-that provides the Recommended Dietary Allowance (RDA) of 15 vitamins and minerals. The benefit of this supplementation over routinely prescribed iron and folic supplementation has been proven in multiple trials. Evidence has shown reduction in low birth newborns.
This randomized controlled trial will compare the effect of calories and multiple micro nutrients provided in energy dense biscuits manufactured by EBM to malnourished pregnant women seen by AKU's Department of Paediatrics and Child Health at their Ali Akbar Shah Goth and Ibrahim Hyderi, compared to food supplementation ration of wheat and oil, plus iron and folic acid tablet supplementation.
Arm 1: Dietary supplementation with EBM biscuits containing multiple vitamins and calcium in the recommended allowance (RDA) for pregnant women Arm 2: Supplementation with Wheat flour and oil, iron and folic acid All undernourished pregnant females identified before 14 weeks of gestation through our surveillance system will be offered enrollment.
First contact: First meeting will be on enrollment. Patients will be randomized into any one of the arm. After randomization Weight, height, MUAC and BMI will be recorded. Samples for Ferritin & hemoglobin will be drawn. In Arm 1 participant will be supplied with energy dense biscuits while in arm 2 will be provided with Wheat flour and oil after every two weeks.
End of each trimester: In second(20-22 week) & third trimester(33-35 week) weight, MUAC & BMI will be recorded. Supplementation will be given according to the Arm. Samples will also be drawn for Ferritin & hemoglobin on third visit. Also at the third trimester visit palatability, accessibility and compliance with biscuits will be assessed by filling a preformed questionnaire.
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
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All pregnant females with gestational age ≤14 weeks and Body mass index(BMI) <18.5
排除标准
- •Pregnant females with underlying chronic illness (cardiovascular disease, diabetes, renal disease, and hypertension)
- •Pregnant females with history of multiple abortions ( two or more abortions)
- •Pregnant females identified as having twin/triplet pregnancies
- •Pregnant females not consenting to participate
- •Pregnant females who are already enrolled in any other study that may interfere with the results of this study
结局指标
主要结局
Neonatal birth weight
时间窗: within 48 hours of birth
Newborns will be captured within 48 hours of their birth and their birthweight will be measured
次要结局
- Maternal weight gain(on enrolment,20-22 week, 33-35 week of gestation)
- Maternal Hemoglobin and Ferritin(On enrollment and last visit (33-35 weeks of gestation))
- Palatability, acceptability, and compliance of the biscuits(On last visit (33-35 weeks of gestation))
研究者
Dr Faraz Naz Qamar
Assistant professor
Aga Khan University