Therapeutic Effects of Oat-based Cereal on Fetomaternal Outcomes Among Hypocalcemic Antenatal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- maternal serum Calcium and Vitamin D concentrations
研究概览
简要总结
This study evaluates the therapeutic effects of an oat-based porridge composite on fetomaternal outcomes and calcium/ vitamin D status among hypocalcemic antenatal women. Pregnant women diagnosed with hypocalcemia are evaluated to determine the efficacy of composite cereal supplementation alongside standard medical care. Blood samples collected at the 8th and 33rd weeks of gestation are analyzed to assess changes in serum calcium and Vitamin D concentrations. The study aims to evaluate whether oat-based porridge supplementation provides beneficial nutritional support for managing hypocalcemia during pregnancy.
详细描述
Pregnant women diagnosed with hypocalcemia are enrolled and allocated into two primary study groups: a control group (T0) receiving standard clinical care (calcium and Vitamin D supplementation as prescribed by attending physicians) and an interventional group(Ta) receiving an optimized oat-based composite porridge formulation in combination with standard supplementation.
The composite oat-based porridge formulations (composed of oats, chickpeas, almonds, chia seeds, and sorghum) are designed to improve maternal mineral adequacy. Maternal blood samples are drawn at baseline (8th week of gestation) and follow-up (33rd week of gestation) to measure changes in serum calcium (mg/dL) and Vitamin D (ng/mL) concentrations, as well as to assess related fetomaternal health parameters from baseline to delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Already taking vitamin D and calcium supplements as prescribed by the doctor.
- •Pregnant women in their 2nd and 3rd trimester.
- •Women between 20 to 40 years of age will be included.
- •Women with mild to moderate hypocalcemia (serum calcium less than 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study.
排除标准
- •Women having twin pregnancy.
- •Gestational diabetes or diabetes before pregnancy.
- •Chronic hypertension.
- •Fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition.
- •Use of anti-convulsive and immunosuppressive drugs.
研究组 & 干预措施
CONTROL GROUP
Participants receiving standard supplementation of calcium and vit.D
干预措施: Calcium & Vitamin D3 supplementation (Dietary Supplement)
EXPERIMENTAL GROUP
Participants receiving standard supplementation of calcium and vit.D along with interventional Oat-Based Porridge
干预措施: Oat-Based porridge (Dietary Supplement)
EXPERIMENTAL GROUP
Participants receiving standard supplementation of calcium and vit.D along with interventional Oat-Based Porridge
干预措施: Calcium & Vitamin D3 supplementation (Dietary Supplement)
结局指标
主要结局
maternal serum Calcium and Vitamin D concentrations
时间窗: .Blood samples were collected at the 8th and 33rd weeks of gestation to assess changes in plasma calcium concentration through blood sampling, from enrollment to delivery .
Evaluating using maternal blood samples to measure change in serum calcium levels in mg/dL And Vitamin D Levels in ng/mL from baseline to delivery.
次要结局
- Incidence of Fetomaternal Complications(Throughout Pregnancy upto delivery)
研究者
Wajeeha Sultana
Principal Investigator
University of Lahore Hospital (ULH)