Pregnancy Outcome Among Vitamin D Supplementation During PregnancyPhase 3NCT04591847
Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy
A Phase 3 study testing Vitamin D 2 in people with Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy
- What is being tested?
- Vitamin D 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 19 Oct 2020to 31 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Thai female
- Singleton pregnancy
- Age at 18 years old or more
- Gestational age at 18-22 weeks
- Accept to enroll
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Vitamin D 2, Placebo drug
- Keywords
- Vitamin D, 25-hydroxyvitamin D, Pregnancy, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 2Drug
Vitamin D2 20000IU 1 tab oral weekly
Placebo drugDrug
Placebo drugs 1 tab oral weekly
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplemented group | Experimental | Vitamin D2 20000 IU 1 tab oral weekly start at GA 18 -22 weeks until delivery Receives: Drug: Vitamin D 2 |
| Placebo group | Experimental | Placebo drug (Appearance same as Vitamin D2) 1 tab oral weekly start at GA 18 -22 weeks until delivery Receives: Drug: Placebo drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-OH vitamin D level in pregnant women
measure in nmol/L
Measured: At delivery time
Serum 25-OH vitamin D level in umbilicalcord blood
measure in nmol/L
Measured: At delivery time
Secondary outcomes (5)
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
Measured: During pregnancy until delivery
Preterm birth
Delivery before GA 37 weeks
Measured: 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
Measured: At delivery time
Infant birth weight
measure in kilograms
Measured: At delivery time
Infant length
measure in centimeters
Measured: At delivery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Oct 2020
- Primary completion31 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Outcome Among Vitamin D Supplementation During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591847
- Sponsor's protocol ID
- 121/2563
- Status last verified
- Oct 2020
- First submitted
- 14 Sep 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes and Vitamin D Level Among Vitamin D Supplementation During Pregnancy : A Double-blind Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04591847
- Acronym / sponsor ID
- 121/2563
- Keywords
- Vitamin D, 25-hydroxyvitamin D, Pregnancy, Infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplemented group | Experimental | Drug: Vitamin D 2Vitamin D2 20000 IU 1 tab oral weekly start at GA 18 -22 weeks until delivery |
| Placebo group | Experimental | Drug: Placebo drugPlacebo drug (Appearance same as Vitamin D2) 1 tab oral weekly start at GA 18 -22 weeks until delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Thai female
- Singleton pregnancy
- Age at 18 years old or more
- Gestational age at 18-22 weeks
- Accept to enroll
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D 2Vitamin D2 20000IU 1 tab oral weekly | Drug | Vitamin D supplemented group |
| Placebo drugPlacebo drugs 1 tab oral weekly | Drug | Placebo group |
Primary outcome
Serum 25-OH vitamin D level in pregnant women
Time frame: At delivery time
measure in nmol/L
Serum 25-OH vitamin D level in umbilicalcord blood
Time frame: At delivery time
measure in nmol/L
5 secondary outcomes
Preeclampsia
Time frame: During pregnancy until delivery
Preterm birth
Time frame: At delivery time
Infant APGAR score
Time frame: At delivery time
Infant birth weight
Time frame: At delivery time
Infant length
Time frame: At delivery time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D 2 in people with Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25-OH vitamin D level in pregnant women (time frame: At delivery time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.