Effect of supplementation of Lactobacillus plantarum UBLP-40 in addition to oral iron on iron status in nonanemic pregnant women with iron deficiency – a double blind placebo-controlled study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- 1.Mean change in ferritin levels as compared to baseline
研究概览
简要总结
The primary objective of the study is to evaluate the effect of 12 weeks supplementation of L plantarum UBLP-40 supplementation combined with oral IFA supplementation as compared to IFA alone on ferritin levels in non-anemic pregnant women with iron deficiency during second trimester. Age-eligible pregnant women will be identified from the affiliated antenatal facility and will be approached for participation in the study. Initially, capillary hemoglobin level will be measured using Hemocue method. Those with Hb>=11 gm% will be invited to the study clinic for further screening. During the screening visit, a blood sample of 5 ml will be collected for estimation of ferritin and CRP levels. Those eligible for participation will be consented for the main study and will be randomized to receive either test or placebo intervention for a period of 12 weeks. The field team will be responsible for monitoring of compliance and collection of adverse events if any. Blood samples will be collected at the end of the intervention and at 35 weeks to assess hematological outcomes (hemoglobin, ferritin and CRP). A telephonic follow-up will be done during postpartum period to note the birth outcome. In a sub-sample of 15 participant per group, fecal samples will be collected for assessment of gut microbiome before and at the end of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy pregnant women aged 18-35 years of age
- •Single live fetus of 12-16 weeks of gestation (USG confirmation)
- •Hemoglobin more than or equal to 11 gm% within 15 days before the enrollment
- •Iron deficiency as demonstrated by serum ferritin levels less than 15 ng per ml or less than 30 ng per ml in case of inflammation (CRP more than or equal to 5 mg per dl)
- •Willing to stay in the study area during the study duration.
排除标准
- •Women with significant medical co-morbidities
- •Women with bad obstetric history
- •Women who have consumed probiotic supplements within 15 days before study participation
- •Not willing to sign written informed consent.
结局指标
主要结局
1.Mean change in ferritin levels as compared to baseline
时间窗: at the end of 12 weeks on intervention
2. Mean change in total hemoglobin as compared to baseline
时间窗: at the end of 12 weeks on intervention
次要结局
- Mean change in hemoglobin levels(35 weeks of gestation)
- Mean change in ferritin levels(35 weeks of gestation)
- Mean change in reticulocyte hemoglobin levels(at the end of intervention and 35 weeks of pregnancy.)
- 4. Proportion of participants with iron deficiency, anemia and iron deficiency anemia(at the end of the intervention and 35 weeks of gestation)
- Mean change in RBC and reticulocyte indices(at the end of the intervention and 35 weeks of gestation)
- Change in gut microbiome will be estimated using 16sRNA analysis in the subgroup(at the end of the intervention)
研究者
Aditi Apte
KEM Hospital Research Centre Pune