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The Effects of Vitamin D2 Supplement During Pregnancy

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ClinicalTrials.gov Identifier: NCT03743922
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

Brief Summary:
The effects of vitamin D2 supplement during pregnancy on postpartum maternal and fetal vitamin D levels: the randomized controlled trial

Condition or disease Intervention/treatment Phase
Pregnancy Early Drug: Calciferol Drug: Placebo Not Applicable

Detailed Description:
Vitamin D structurally similar to steroids. Made from the skin. And metabolism of the liver, kidneys, vitamin D levels in the bloodstream are two types of vitamin D 2 (Ergocalciferol) and vitamin D 3 (Cholecalciferol) Vitamin D regulates calcium and phosphorus levels in the body. Including the accumulation of minerals in the bone. Vitamin D is important in the formation of bones and teeth and the normal growth of children, affects the reabsorption of amino acids in the kidneys, regulates the amount of calcium and phosphorus in the blood Vitamin D deficiency in pregnant affects the mother and baby example high maternal blood pressure during pregnancy, diabetes during pregnancy, increase birth body weight of baby. low calcium seizures Infants, baby have bones and growth disorders. Currently, no vitamin D supplement is used in pregnant women in Thailand who attend antenatal clinics. The researcher has proposed to study the effects of vitamin D supplement during pregnancy on postpartum maternal and fetal vitamin D levels by using vitamin D 20,000IU / week

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Vitamin D2 Supplement During Pregnancy on Postpartum Maternal and Fetal Vitamin D Levels: the Randomized Controlled Trial
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral calciferol group
Subjects will receive oral calciferol 20,000 iu per week during pregnancy until delivered
Drug: Calciferol
calciferol capsule
Other Name: vitimin d2

Placebo Comparator: oral placebo group
Subjects will receive oral placebo 1 tab per week during pregnancy until delivered
Drug: Placebo
placebo capsule
Other Name: placebo ( for calciferol )




Primary Outcome Measures :
  1. effect of vitamin D 2 supplementation during pregnancy [ Time Frame: within 30 minute after delivered ]
    To study the effect of vitamin D 2 supplementation during pregnancy on postpartum maternal and fetal vitamin D levels effects of vitamin D2 supplement during pregnancy on postpartum maternal and fetal vitamin D levels


Secondary Outcome Measures :
  1. vitamin D levels in maternal blood during pregnancy [ Time Frame: at first time ANC ]
    To assess vitamin D levels in maternal blood during pregnancy

  2. vitamin D levels in maternal blood after vitamin D supplementation [ Time Frame: within 30 minute after delivered ]
    To assess vitamin D levels in maternal blood after vitamin D supplementation during pregnancy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who have pregnant and ANC at Rajavithi hospital
  • Women who have age at least 18 year
  • Women who have Thai nationality
  • Women who have pregnant of gestational age under 20week

Exclusion Criteria:

  • Women who don't plan of delivered at Rajavithi hospital
  • Women who have complication of pregnancy
  • Woman who delivered before gestational age 37week
  • Women who have abnormal kidney function
  • Woman who have been used anticonvulsant drug or others form of vitamin d
  • Women who have vitamin d allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743922


Contacts
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Contact: Patitta Vacharaprechaskul 0809091067 lovelytip7@gmail.com
Contact: Charuwan Manmee 023548108 ext 2803 charuwan_manmee@yahoo.com

Sponsors and Collaborators
Rajavithi Hospital
Investigators
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Principal Investigator: Patitta Vacharaprechaskul Rajavithi Hospital
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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT03743922    
Other Study ID Numbers: THAIVITD2
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ergocalciferols
Cholecalciferol
Vitamin D
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents