ISRCTN83599025已完成不适用
GIFTS Work Package 3: Pilot intervention in pregnant women in Bangladesh to observe the effect of lifestyle and nutritional intervention in pregnancy and foetal outcomes relevant to metabolic diseases
Queen Mary University (UK)0 个研究点目标入组 1,200 人开始时间: 2014年7月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29850608
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women in the 1st trimester of pregnancy
- •2. Age between 18 to 28 years
- •3. Primigravida/multigravida (maximum two previous deliveries)
- •4. Conception without treatment of infertility
- •5. Planned hospital delivery
- •6. Able to provide informed consent for participation in the trial
- •7. Singleton pregnancy
- •8. From middle and low socioeconomic background (less than 10,000 Taka – US $ 150, monthly household income)
- •9. Presenting to antenatal clinics, in 10 locations in Azimpur near Dhaka, Bangladesh
- •Added 17/08/2015:
- •Participant criteria added (points 8 and 9)
排除标准
- •1. Pre-pregnancy diabetes (previously diagnosed or by OGTT at 12-14 weeks gestation
- •2. History congenital malformations
- •3. Planned home delivery
- •4. Multiple pregnancies
- •5. Known intolerance to any of the micronutrient supplements being administered in the trial
- •6. Prior history of hypercalcaemia or renal stones
- •7. Serum calcium >2.65 mmol/L
- •8. Participation in another trial/study likely to impact the results of this study
- •9. CKD stage 4 or worse defined by eGFR <30 mL/min/1.73m2
- •10. History of significant liver disease ? AST > 3xULN or bilirubin >2.5xULN
- •11. Active sarcoidosis, tuberculosis or malignancy
- •12. Thyroid disease
- •13. Medication: use of multivitamin supplements, thiazide diuretics or oral corticosteroids in the past one month
研究者
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