Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Hematocrit in Concentration From Baseline to 90 Days
研究概览
简要总结
Hypothesis: Synergistic effect of pre-biotics and iron fortificants will enhance the bioavailability of iron; thereby improving the body iron reserves.
A double blind, randomized controlled trail will be conducted on iron deficient female adults (age 18-25 years) in order to determine the synergistic effect of pre-biotics and iron fortificants in anemic human subjects. 75 iron deficient females will be randomly divided into 5 groups (D0, D1, D2, D3 and D4), each having 15 study subjects and will be given varying doses of FeSO4 and NaFeEDTA and Inulin and GOS. Blood samples will be collected from overnight fasted women from each group on monthly basis up to three months. Various biomarkers for iron absorption, LFTs, RFTs, and Immunoglobulins will be estimated.
详细描述
Study Design A double blind, randomized controlled trial will be used for the purpose of this study.
Study Site The study will be conducted in Islamabad and/or Lahore, depending on the availability of the required sample size with the desired profiles.
Study Duration The trial will last for 12 weeks. Study Population The study population will consist of university going iron deficient female adults (age 18-25 years).
Inclusion and Exclusion Criteria Inclusion Criteria All willing anemic female adults without any chronic diseases such as diabetes or hypertension will be included in the study.
Exclusion Criteria Married females or those with chronic diseases or those already taking iron and/or prebiotic supplements will be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All willing anemic female adults without any chronic diseases such as diabetes or hypertension will be included in the study.
排除标准
- •Married females or those with chronic diseases or those already taking iron and/or prebiotic supplements will be excluded from the study.
研究组 & 干预措施
Prebiotic Inulin & Iron Salt FeSO4
干预措施: Prebiotic + Iron Forificant (Combination Product)
Prebiotic GOS & Iron Salt FeSO4
干预措施: Prebiotic + Iron Forificant (Combination Product)
Prebiotic Inulin & Iron Salt NaFeEDTA
干预措施: Prebiotic + Iron Forificant (Combination Product)
Prebiotic GOS & Iron Salt NaFeEDTA
干预措施: Prebiotic + Iron Forificant (Combination Product)
Placebo only
干预措施: Prebiotic + Iron Forificant (Combination Product)
结局指标
主要结局
Change in Hematocrit in Concentration From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Hemoglobin Concentration From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Volume From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Serum Iron Levels From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Serum Folate Levels From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Serum Ferritin Levels From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Serum Transferrin Levels From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
时间窗: Baseline, 30 days, 60 days, 90 days
次要结局
- Change in Liver Functions Tests (ALT) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Liver Functions Tests (AST) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Liver Functions Tests (ALP) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Immunoglobulins (IgA) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Immunoglobulins (IgE) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Immunoglobulins (IgG) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
- Change in Immunoglobulins (IgM) From Baseline to 90 Days(Baseline, 30 days, 60 days, 90 days)
研究者
ABDUL MOMIN RIZWAN AHMAD
Principal Investigator
University of Veterinary and Animal Sciences, Lahore - Pakistan