Pregnancy ComplicationsNCT02021864
Vitamin D Treatment and Hypocalcemic Pregnant Women
A study testing vitamin D3 50,000 unit and prenatal multivitamin in people with Pregnancy Complications, run by Dr. Sima Hashemipour at 1 site in Iran.
Trial summary
Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study. . Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- vitamin D3 50,000 unit and prenatal multivitamin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- gestational age of 24-26weeks,mild hypocalcemia (ca=8-8.6mg/dl),singleton pregnancy, body mass index (BMI) of 19-26 -
Who cannot join
- moderate to sever hypocalcemia(ca<8mg/dl), gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs
- -
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Qazvin university of medical science, Kosar hospital
Qazvin, Qazvin Province
shokooh Abotorabi, assistant professor, 00989121822663, Abotorabi4242@yahoo.com
shokooh Abotorabi, assistant professor
About this study
Official title: Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia
- Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study. .
- Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs.
- Participants will randomly assigned in to two groups of intervention and control groups .Randomization will be done by random number generator. Intervention group will receive weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily prenatal multivitamin.
- At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length, weight, head circumference ) will be compared between two groups.
- Conditions
- Pregnancy Complications
- Being tested
- vitamin D3 50,000 unit, prenatal multivitamin
- Keywords
- hypocalcemia, pregnancy, vitamin D
- Medical subject headings
- Pregnancy Complications, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3 50,000 unitDrug
vitamin D3 50,000 unit/week for 8 weeks
prenatal multivitaminDrug
daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
| Study group | Role | What they receive |
|---|---|---|
| vitamin D3, prenatal multivitamin | Experimental | vitamin D3 50,000 unit/week for 8 weeks, daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit Receives: Drug: vitamin D3 50,000 unit; Drug: prenatal multivitamin |
| prenatal multivitamin | Active comparator | daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit Receives: Drug: prenatal multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of hypocalcemic subjects at the ens of study
women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.
Measured: 12-14 weeks
Secondary outcomes (1)
Changing of maternal mean calcium level
Measured: 12-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sima Hashemipour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sima Hashemipour, Sina Hospital, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021864
- Sponsor's protocol ID
- hypocalcemia of pregnancy
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.
PubMed 39077939
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia
- ClinicalTrials.gov ID
- NCT02021864
- Acronym / sponsor ID
- hypocalcemia of pregnancy
- Conditions
- Pregnancy Complications
- Keywords
- hypocalcemia, pregnancy, vitamin D
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr. Sima HashemipourUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (estimated)
- First posted
- 27 Dec 2013 (estimated)
- 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.
- Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study. .
- Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs.
- Participants will randomly assigned in to two groups of intervention and control groups .Randomization will be done by random number generator. Intervention group will receive weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily prenatal multivitamin.
- At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length, weight, head circumference ) will be compared between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D3, prenatal multivitamin | Experimental | Drug: vitamin D3 50,000 unit, Drug: prenatal multivitaminvitamin D3 50,000 unit/week for 8 weeks, daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit |
| prenatal multivitamin | Active comparator | Drug: prenatal multivitamindaily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- gestational age of 24-26weeks,mild hypocalcemia (ca=8-8.6mg/dl),singleton pregnancy, body mass index (BMI) of 19-26 -
Key exclusion criteria (2 listed)
- moderate to sever hypocalcemia(ca<8mg/dl), gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs
- -
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 D3 50,000 unitvitamin D3 50,000 unit/week for 8 weeks | Drug | vitamin D3, prenatal multivitamin |
| prenatal multivitamindaily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit | Drug | prenatal multivitamin, vitamin D3, prenatal multivitamin |
Primary outcome
percentage of hypocalcemic subjects at the ens of study
Time frame: 12-14 weeks
women in 24-26 weeks of pregnancy will be enrolled.Outcomes will be measured at delivery time.
1 secondary outcome
Changing of maternal mean calcium level
Time frame: 12-14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Derived from this study: PubMed 39077939Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 50,000 unit and prenatal multivitamin in people with Pregnancy Complications, run by Dr. Sima Hashemipour at 1 site in Iran.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Jan 2014. 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 Iran. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sima Hashemipour, assisstant prefessor (00989123575592, Hashemipour.sima@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of hypocalcemic subjects at the ens of study (time frame: 12-14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02021864, which also lists 1 linked publication.
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 22 Jan 2014.