ISRCTN83599025CompletedNot Applicable
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 sites1,200 target enrollmentStarted: July 30, 2014Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,200
Study Overview
Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29850608
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Investigators
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