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
相似试验
已完成
3 期
A phase III, randomised, controlled trial for the treatment of HIV-associated cryptococcal meningitis: oral fluconazole plus flucytosine or one week amphotericin B-based therapy vs two weeks amphotericin B-based therapyISRCTN45035509St George's University of London (UK)680
已完成
3 期
Clinical trial to assess the importance of nephrectomyMetastatic renal cell carcinoma, clear cell carcinoma (the most common type of renal cell carcinoma).Malignant neoplasm of kidney, except renal pelvisCancerISRCTN19562321HS Greater Glagsow and Clyde (UK)450
终止
3 期
HYMN: a trial comparing hyperthermia and mitomycin chemotherapy with a second BCG treatment, or other standard treatment, for bladder cancer that has come backCancerISRCTN85785327niversity College London (UK)242
已完成
3 期
A randomised, placebo-control phase III study to assess the safety and efficacy of the MPT64 patch test in the diagnosis of active tuberculosis (TB)Active pulmonary tuberculosis.Infections and InfestationsTuberculosisISRCTN49676555Sequella Inc (USA)512
已完成
3 期
SOLE: Study Of Letrozole Extension in post-menopausal women with breast cancerMalignant neoplasm of breastBreast cancerCancerISRCTN43286545European Institute of Oncology (IEO) (Italy)4,884