HealthyNCT01060735
Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age
A study testing Vitamin D in people with Healthy, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to Dec 2013
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women aged 20 to 40 years, of any parity status.
- Signed informed consent
Who cannot join
- Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders
- Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
Raanan Shamir, Professor
Eran Adar, MD
About this study
Official title: The Effect of Different Doses of Vitamin D Supplementation During Pregnancy on Bone and Vitamin D Status in Children at Birth and at One Year Age
Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.
We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.
The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.
Read the detailed description
This is a prospective randomized controlled study.
120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.
25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.
25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.
Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.
Quantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year.
Bone status of newborns at birth and at one year age in children will be compared between the 2 groups.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery
| Study group | Role | What they receive |
|---|---|---|
| Larger doses of vitamin D supplementation | Experimental | The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day Receives: Dietary Supplement: Vitamin D |
| Conventional vitamin D supplementation | No intervention | Regular supplementation during pregnancy with 400IU vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS).
Measured: Bone status in offsprings, assessed at the age of one year
Secondary outcomes (5)
Vitamin D status of mothers.
Measured: At the start of intervention, at delivery and at the age of one year
Maternal health status.
Measured: At the start of intervention, at delivery and at the age of one year
Infants' growth.
Measured: At the start of intervention, at delivery and at the age of one year
Vitamin D status in infants.
Measured: At the start of intervention, at delivery and at the age of one year
Safety of vitamin D supplementation doses.
Measured: At the start of intervention, at delivery and at the age of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Corina Hartman, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060735
- Sponsor's protocol ID
- rmc005437ctil
- Status last verified
- Jul 2011
- First submitted
- 31 Jan 2010
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Doses of Vitamin D Supplementation During Pregnancy on Bone and Vitamin D Status in Children at Birth and at One Year Age
- ClinicalTrials.gov ID
- NCT01060735
- Acronym / sponsor ID
- rmc005437ctil
- Conditions
- Healthy
- Keywords
- Vitamin D, pregnancy, children, bone, quantitative ultrasound, Healthy pregnant women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 Feb 2010 (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.
Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.
We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.
The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.
Detailed description
This is a prospective randomized controlled study.
120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.
25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.
25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.
Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.
Quantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year.
Bone status of newborns at birth and at one year age in children will be compared between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Larger doses of vitamin D supplementation | Experimental | Dietary Supplement: Vitamin DThe subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day |
| Conventional vitamin D supplementation | No intervention | –Regular supplementation during pregnancy with 400IU vitamin D |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy pregnant women aged 20 to 40 years, of any parity status.
- Signed informed consent
Key exclusion criteria (2 listed)
- Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders
- Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents
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 DVitamin D 2000iu/ day from the 27 week of pregnancy up to delivery | Dietary supplement | Larger doses of vitamin D supplementation |
Primary outcome
Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS).
Time frame: Bone status in offsprings, assessed at the age of one year
5 secondary outcomes
Vitamin D status of mothers.
Time frame: At the start of intervention, at delivery and at the age of one year
Maternal health status.
Time frame: At the start of intervention, at delivery and at the age of one year
Infants' growth.
Time frame: At the start of intervention, at delivery and at the age of one year
Vitamin D status in infants.
Time frame: At the start of intervention, at delivery and at the age of one year
Safety of vitamin D supplementation doses.
Time frame: At the start of intervention, at delivery and at the age of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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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.
Corina Hartman, MD principal investigator
Rabin Medical Center
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 D in people with Healthy, run by Rabin Medical Center at 1 site in Israel.
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 2 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 Jul 2011. 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 Israel. 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 Corina Hartman, MD (972-3-9253674, corinah@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS). (time frame: Bone status in offsprings, assessed at the age of one year). 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 22 Jul 2011.