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临床试验/CTRI/2025/02/081056
CTRI/2025/02/081056尚未招募不适用

Maternal Vitamin B12 status during pregnancy:Association of low vitamin B12 with markers of oxidative stress- MPO,Ox-LDL and IsoPs

All India Institute of Medical Sciences Rajkot1 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
385
试验地点
1
主要终点
Vitamin B12 deficiency anemia in pregnant females causes oxidative stress and poses risk to both mother and the foetus

研究概览

简要总结

A.    Background- Nutritional deficiencies among pregnant women is a public health problem of global concern. It is the most frequently encountered problem in pregnant women in India, & is a major cause of maternal and fetal complications including mortality. Vitamin B12 deficiency is an important contributor to deficiency manifestations, in addition to iron and folate deficiency. In India, anemia during pregnancy is a significant public health problem, with 45.7% of pregnant women in urban areas and 52.1% in rural areas having hemoglobin levels <11 g/dl.

B.    Objectives- a) To measure levels of oxidative stress markers – MPO, Ox-LDL & IsoPs in pregnant females having a vitamin B12 deficiency b) To detect vitamin B12-mediated oxidative damage in the mothers.

C.     Methodology- It is a hospital-based cross-sectional study. The study will be carried out in the Clinical Biochemistry lab in collaboration with the Department of Obstetrics & Gynecology & Department of Pathology at AIIMS, Rajkot. The pregnant females coming for their antenatal visits will be selected from the outpatient department of Obstetrics & Gynecology. Patients showing signs & symptoms of anemia will be the main target group of this study. Diagnosis of anemia will be made using the following WHO criteria: hemoglobin levels less than 11.0 g/dl in the first and third trimesters and less than 10.5 g/dl in the second trimester with the presence of signs and symptoms. The patients having Vitamin B12 deficiency (Vit B12 levels - 1st trimester 118 - 438 pg/ml, 2nd trimester 130 - 656 pg/ml, 3rd trimester 99 - 526 pg/ml) will be differentiated from patients having Iron deficiency (Ferritin levels <10 Microgm/L). Inclusion criteria: All pregnant females (age group 18 – 40 years) with Vitamin B12 deficiency, irrespective of their gestational age. All subjects will be undergoing interviews using questionnaires. The sample size will be of 385.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant patients having Vitamin B12 deficiency anemia not taking Vitamin B12 supplements with Hb levels less than 11 gm/dl.

排除标准

  • Chronic illness like diabetes mellitus, hypertension, cancer, iron deficiency anemia.

结局指标

主要结局

Vitamin B12 deficiency anemia in pregnant females causes oxidative stress and poses risk to both mother and the foetus

时间窗: at baseline

次要结局

  • Fetal growth retardation & premature or preterm delivery(at the time of delivery)

研究者

发起方
All India Institute of Medical Sciences Rajkot
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anita Motiani

All India Institute of Medical Sciences, Rajkot

研究点 (1)

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