Impact of Antenatal Multiple Micronutrient (Folic acid and Niacin and Iron) vs Folic Acid Supplementation on Nutritional Biomarkers
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change in maternal hemoglobin Hb gL from baseline to 20 weeks of gestation in both treatment arms
研究概览
简要总结
| The study will be initiated after obtaining written approval from the ethics committees of all study sites. Pregnant women 18 to 35 years will be enrolled if they provide written informed consent and satisfy all eligibility criteria. All possible demographic medical history comorbidities and other relevant clinical details will be recorded at baseline. Patients will undergo standard care as per routine practice in both treatment arms along with the test medication in treatment arm A and folic acid in treatment arm B. |
Enrolled subjects will be allotted in a ratio 11 into two treatment arms i subjects in the treatment arm A will undergo treatment with standard of care along with PreNatal**®**tablet 1 tablet once daily OD till 40 weeks of gestation ii subjects in the treatment arm B will undergo treatment with standard of care along with folic acid 5 mg OD.
During inperson visits physical examination and examination of vital signs and clinical features will be done along with recording AEs concomitant medications and treatment compliance from baseline till week 40delivery. After clinical assessments blood samples 10 mL of venous blood from each subject will be collected and sent to the partner laboratory to estimate the maternal hemoglobin Hb gL maternal serum niacin nmolL and maternal serum folate nmolL at baseline and 20 weeks of gestation. All inperson visits after baseline are scheduled at 12th 20th 32nd weeks of gestation and the end of week 40delivery.Fetal parameters and maternal outcomes will be assessed at all in person visits during gestation and at delivery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Time elapsed from the first day of the last menstrual period (LMP) not more than 8 weeks Singleton live pregnancy Willingness to provide written informed consent.
排除标准
- •Women with severe anemia ( Hb 7g/L) Recent consumption of antifolates (like methotrexate) folic acid antagonists (like valproic acid) or any medications known to interfere with folate absorption as per Investigator’s discretion Prior pregnancy with neural tube defect (NTD) or any other congenital defect Diagnosis of neural tube defect (NTD) in the biological father of the fetus or any blood relative of the patient Diagnosis of epilepsy and seizure disorders History of tumor Family history of reproductive organ cancer History of clinically significant complications including renal disease with altered renal function History of any condition that could interfere with folate absorption or metabolism such as clinically significant gastrointestinal disease like chronic diarrhea inflammatory bowel disease partial gastrectomy unresolved gastrointestinal symptoms like diarrhea vomiting steatorrhea Pre existing maternal diabetes or insulin dependent diabetes Alcohol abuse during current pregnancy Illicit drug use during the current pregnancy as per the Investigator’s judgment Known allergy hypersensitivity proven inefficiency or contraindications to the study medication any of its excipients or products containing any of the excipients Participation in another clinical trial concurrently or within 30 days before screening Planned participation in any other trial during the entire duration of the study Refusal or inability to comply with the requirements of the protocol for any reason Any other condition in the patient which in the opinion of the Investigator could confound the results of the trial put the patient at undue risk, or make the patient unsuitable for participation.
结局指标
主要结局
Change in maternal hemoglobin Hb gL from baseline to 20 weeks of gestation in both treatment arms
时间窗: To evaluate the effectiveness of L methylfolate niacin and iron based periconceptional supplementation compared to folic acid alone in improving maternal biomarkers related to nutritional status and anemia prevention
Change in maternal serum niacin nmolL levels from baseline to 20 weeks of gestation in both treatment arms
时间窗: To evaluate the effectiveness of L methylfolate niacin and iron based periconceptional supplementation compared to folic acid alone in improving maternal biomarkers related to nutritional status and anemia prevention
Change in maternal serum folate nmolL levels from baseline to 20 weeks of gestation in both treatment arms
时间窗: To evaluate the effectiveness of L methylfolate niacin and iron based periconceptional supplementation compared to folic acid alone in improving maternal biomarkers related to nutritional status and anemia prevention
次要结局
- Proportion of participants experiencing maternal side effects (eg fatigue nausea vomiting) till 40 weeks or delivery in both treatment arms(Proportion of participants experiencing maternal morbidity outcomes pre eclampsia or eclampsia gestational hypertension premature rupture of membranes placental abruption infection during pregnancy need for blood transfusion) at week 40 or delivery in both treatment arms.)
研究者
Palaniappan N
Sri Ramachandra Institute of Higher education and Research