A randomized controlled clinical trial to compare the efficacy of Vitamin D vs placebo to reduce high blood sugar during pregnancy
Phase 4
- Conditions
- Gestational diabetes
- Registration Number
- SLCTR/2018/020
- Lead Sponsor
- Colombo North Teaching Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. Pregnant women
2. Aged 18-40 years
3. Diagnosed as a Gestational diabetes by 75g Oral Glucose tolerance test
4. On medical nutritional therapy and/or metformin.
Exclusion Criteria
1. Premature pre-labour rupture of membrane
2. Existing liver or kidney disease
3. Placental abruption
4. Pregnancy induced hypertension or Pre eclampsia
5. Diagnosed with Type 2 diabetes mellitus
6. Need insulin therapy during the intervention or already on insulin therapy
7. Smoking
8. Diagnosed with hypothyroidism
9. Diagnosed with calcium or vitamin D metabolism disorders
10. Already on Vitamin D supplementation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean difference of blood glucose levels in the two arms before and after the intervention.<br><br>Blood glucose levels will be measured by fasting blood sugar (FBS) test and 1hour post prandial blood sugar (PPBS) (post breakfast) test<br><br> [Day1 (before the intervention) and after 4 weeks of intervention.]<br>
- Secondary Outcome Measures
Name Time Method