Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy
Conditions
Keywords
Vitamin D, 25-hydroxyvitamin D, Pregnancy, Infant
Brief summary
To compared pregnancy outcome (Serum vitamin D level in mother and infant , preeclampsia rate, preterm birth rate, Infant birth weight, Infant length , APGAR score) between pregnant women who were given vitamin D supplementation and pregnant women who were given placebo
Interventions
DRUGVitamin D 2
Vitamin D2 20000IU 1 tab oral weekly
DRUGPlacebo drug
Placebo drugs 1 tab oral weekly
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Thai female * Singleton pregnancy * Age at 18 years old or more * Gestational age at 18-22 weeks * Accept to enroll
Exclusion criteria
* Pregnant women who not planned to delivery at Rajavithi hospital * Abnormal kidney function * Use antiepileptic drugs , or vitamin D supplementation * Allergy to vitamin D * Who were diagnosed as vitamin D deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum 25-OH vitamin D level in pregnant women | At delivery time | measure in nmol/L |
| Serum 25-OH vitamin D level in umbilicalcord blood | At delivery time | measure in nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant APGAR score | At delivery time | Measure at delivery time score 10/10 Appearance : Cyanotic, pale all over = 0 , Peripheral cyanotic only = 1 , Pink = 2 Pulse : 0 bpm = 0 , \<100 = 1, 100-140 = 2 Grimace : no response to stimulation = 0 , Grimace(facial movement ,weak cry) = 1 Cry when stimulated = 2 Activity (tone) : floppy = 0 , Some flexion = 1 , Well flexed and resisting extension = 2 Respiration : Apnoeic = 0 , Slow irregular = 1 , Strong cry = 2 |
| Preeclampsia | During pregnancy until delivery | Measure by clinical and laboratory of preeclampsia ้high blood pressure ( \>= 140/90 mmHg) with proteinuria (UPCI \> 0.3 mg/dL or Urine protein 24 hours \> 300 mg) or in absence of proteinuria with new onset of any of the following * thrombocytopenia : Platelet count less than 100,000 x 10\^9 /L * Serum creatinine \> 1.1 mg/dL or doubling of the serum creatinine * Elevated liver transaminases to twice normal * Pulmonary edema * New onset headache unresponsive to medication * Visual symptom |
| Infant length | At delivery time | measure in centimeters |
| Infant birth weight | At delivery time | measure in kilograms |
| Preterm birth | At delivery time | Delivery before GA 37 weeks |
Countries
Thailand
Outcome results
None listed