GIFTS: Mother and Child Health Study

Completed

• Conditions: Diabetes, obesity, pregnancy; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN83599025
• Lead Sponsor: Queen Mary University (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-30
• Study Completion: 2015-08-01
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified