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Clinical Trials/ISRCTN83599025
ISRCTN83599025
Completed
Not 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 enrollmentJuly 30, 2014
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Queen Mary University (UK)
Enrollment
1200
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29850608

Registry
who.int
Start Date
July 30, 2014
End Date
August 1, 2015
Last Updated
7 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Queen Mary University (UK)

Eligibility Criteria

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:

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

Outcomes

Primary Outcomes

Not specified

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