Diabetes, obesity, pregnancy Nutritional, Metabolic, Endocrine
Conditions
Interventions
Control Arm 1 - Usual Care:
1. Subjects: With nutritional deficiencies
2. Randomized
3. Vitamin D: as per obstetricians standard care
vitamin D is not usually measured
4. Vitamin B12: as per obstetricians standard care
vitamin B12 is not usually measured
5. Folate/iron: supplementation (400 mcg/day) throughout pregnancy and iron capsules from 2nd trimester as per obstetricians standard care
6. Lifestyle: as per o
vitamin B12 is not usually measured
5. Folate/iron: supplementation (400 mcg/day) throughout pregnancy and iron capsules from 2nd trimester as per obstetricians standard care
6. Lifestyle: as per obs
Sponsors
Queen Mary University (UK)
Eligibility
Sex/Gender
Female
Inclusion 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: Participant criteria added (points 8 and 9)
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Will be a composite based on maternal micronutrients at term by increasing total vitamin D repletion (>80 nmol/l) to 40% (compared to an estimated 10% repletion in the usual care) and decreasing vitamin B12 deficiency (<200 pg/ml) to 5% (compared to an estimated 15% in usual care) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fetal (taken at delivery): 1. Cord blood insulin (this endpoint has helped inform sample size; see power calculations), C-peptide and other biochemistry 2. Anthropometric measurements including customized birthweights 3. Nutritional levels (vitamin D, vitamin B12, folate, homocystene and other detailed measurements, including leptin) 4. DNA methylome 5. Identification of ideal birth weight Maternal (taken in the 1st trimester, at 24-28 weeks, and at delivery): 1. In those overweight a weight loss of 5% compared to usual care 2. Anthropometric measurements 3. Biochemistry, including folate, homocystene H (and detailed 1C metabolites), leptin 4. Incidence of GDM defined by local criteria 5. Identification of ideal weight gain during pregnancy 6. Change of maternal vitamin D status as a predictor of changes in fetal anthropometric and biochemical markers of cardiometabolic risk; plus as preceding but also accounting for vitamin D related genotypes 7. Change of maternal 1C status as a predictor of changes in fetal anthropometric and biochemical markers of cardiometabolic risk; plus as preceding but also accounting for genotype for instance MTHFR, FUT2 Feasibility: 1. Feasibility and acceptability of intervention 2. Ratio of pregnant women consented compared to cord bloods collect 3. Concordance with lifestyle and vitamin D/vitamin B12 dosing | — |
Countries
Bangladesh
Outcome results
None listed