Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy

Pregnancy Outcomes and Vitamin D Level Among Vitamin D Supplementation During Pregnancy : A Double-blind Randomized Placebo Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy
• Intervention / Treatment: Drug: Vitamin D 2; Drug: Placebo drug

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin D supplemented group; Vitamin D2 20000 IU 1 tab oral weekly start at GA 18 -22 weeks until delivery	Drug: Vitamin D 2; Vitamin D2 20000IU 1 tab oral weekly
EXPERIMENTAL: Placebo group; Placebo drug (Appearance same as Vitamin D2) 1 tab oral weekly start at GA 18 -22 weeks until delivery	Drug: Placebo drug; Placebo drugs 1 tab oral weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum 25-OH vitamin D level in pregnant women	measure in nmol/L	At delivery time
Serum 25-OH vitamin D level in umbilicalcord blood	measure in nmol/L	At delivery time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preeclampsia	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	During pregnancy until delivery
Preterm birth	Delivery before GA 37 weeks	At delivery time
Infant APGAR score	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	At delivery time
Infant birth weight	measure in kilograms	At delivery time
Infant length	measure in centimeters	At delivery time

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2020
• Primary Completion (ACTUAL): July 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Vitamin D; Pregnancy; Infant; 25-hydroxyvitamin D
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Ergocalciferols
• Other Study ID Numbers: 121/2563

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No