Vitamin D DeficiencyNCT02743559
Does Vitamin D Alter Bone's Response to Vibration?
A study testing Mechanical Stimulation using whole body vibration in people with Vitamin D Deficiency and Osteoporosis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Fractures in children are common and the incidence is increasing. They are more common in children who have small, narrow and weak bones. Studies have shown that fractures in early childhood are associated with later bone strength. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Vitamin D Deficiency, Osteoporosis
- What is being tested?
- Mechanical Stimulation using whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2016to 1 Mar 2018
- 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 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children born to mothers who participated in MAVIDOS trial in Sheffield free from any condition affecting bone health, general nutrition, growth and glucose metabolism will be invited to enrol in the study.
Who cannot join
- Children with (1) balance problems, (2) current or healing fractures (3) any chronic illness involving the bone, liver and kidney (4) current long-term use of steroids, anticonvulsants or any medication that might affect calcium and vitamin D metabolism will be identified from through a questionnaire and excluded.
- Participants will fill in questionnaires to estimate their calcium intake and Vitamin D exposure and this will be included in the analysis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: Does Antenatal Vitamin D Supplementation Influence Bone's Postnatal Response to Mechanical Stimulation?
Fractures in children are common and the incidence is increasing. They are more common in children who have small, narrow and weak bones. Studies have shown that fractures in early childhood are associated with later bone strength.
There are several (i) non-modifiable (age, gender, race, genetics) and (ii) modifiable factors such as nutrition (vitamin D \& calcium intake) and exercise that can contribute to bone strength.
Read more
Low calcium is associated with an increased risk of fracture. Vitamin D plays a pivotal role in bone health by increasing the absorption of calcium from the gut. Investigators know from the previous research that there is a reduction in bone strength in children whose mothers had lower vitamin D levels during pregnancy.
Bone growth can also be achieved by loading of bone during childhood in the form of regular sport activities such as gymnastics and exercise programmes. Equally it can be achieved by using whole body vibration (WBV). WBV is the application of vibratory stimulus to the body in a synchronous fashion by which the bones are made much stronger reducing the risk of fracture in later life. Thus WBV can be used as a means to assess bone responsiveness to mechanical stimulation. Studies have shown that standing on a vibrating platform for 10 minutes a day can significantly increase the bone mass. Investigators' own research has also shown that healthy boys when made to stand on a vibration platform for 10 minutes daily for 5 days increased the strength and quality of their bones.
Thus the role of diet and mechanical loading are of considerable interest in determining their role in bone health and the prevention of fractures.
Maternal Vitamin D Osteoporosis Study (MAVIDOS) is a large study conducted recently at 3 different big centres (Sheffield, Southampton and Oxford). Results from this study have shown that giving a higher dose of vitamin D to pregnant women every day from 14 weeks of pregnancy increased the strength of the bones in their infants. In the proposed study Investigators aim to show how vitamin D supplementation during pregnancy affects the response of bone to vibration in children whose mothers participated in the MAVIDOS study in Sheffield. These children will be 4 years of age when they participate in this study.
The results of this study will help inform public health policy on vitamin D intake during pregnancy. This will also help the investigators identify a possible risk factor for poor bone health in children.
Read the detailed description
This project aims to determine whether antenatal vitamin D supplementation alters postnatal bone formation in response to mechanical stimulation.
The skeleton responds to mechanical stimulation by an increase in bone size and mass and that increment can persist into adult life and may lower the risk of osteoporosis (Daly, \& Bass, 2009). In contrast, without mechanical stimulation, bone is lost.
Cells within bone - osteoblasts and osteoclasts - are involved in the removal and formation of bone; the biomarkers Pro-collagen type 1 N-terminal propeptide (PINP) and C-terminal cross-linked telopeptide of type I collagen (CTx) are surrogates for their respective tissue level activities.
Whole body vibration (WBV) has been used as one of the methods to deliver mechanical stimulation in both adults and children.
The investigators have recently shown in healthy boys aged 9-11 years, WBV experienced 10 minutes daily for five days increases the P1NP by 25% and CTx by 11% (Harrison et al., 2015).
The investigators undertook another study recently to determine the effect of reduced vitamin D intake during pregnancy and early life on the skeleton's response to mechanical loading using a mouse model.
Our unpublished data show that antenatal vitamin D depletion substantially reduces the loading-dependent increase in both cortical and trabecular bone mass of offspring mice close to skeletal maturity.
The available human and mouse data suggest that antenatal vitamin D deficiency in some way influences the bone to become less responsive to mechanical stimulation.
The investigators are now ready to explore this in humans, to assess the responsiveness of the skeleton to mechanical stimulation by using WBV in the children who have been exposed to higher levels of vitamin D in-utero through maternal supplementation of vitamin D.
Through this study the investigators will be able to determine whether the in-utero environment can be modified easily to improve the skeletal responsiveness to activity and this improved skeletal health in the short and long term.
- Conditions
- Vitamin D Deficiency, Osteoporosis
- Being tested
- Mechanical Stimulation using whole body vibration
- Medical subject headings
- Vitamin D Deficiency, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Stimulation using whole body vibrationDevice
All participants will undergo whole body vibration (WBV) by standing on the LivMD WBV platform on 5 consecutive mornings
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Active comparator | Children born to mothers who received vitamin D during pregnancy will undergo mechanical stimulation using whole body vibration(WBV) by standing on the vibration platform(LivMd) for 10 minutes on 5 consecutive mornings, at 7.30-8 am. Receives: Device: Mechanical Stimulation using whole body vibration |
| Placebo group | Placebo comparator | Children born to mothers who received placebo during pregnancy will also undergo mechanical stimulation using whole body vibration(WBV) by standing on the vibration platform (LivMd) for 10 minutes on 5 consecutive mornings, at 7.30-8 am. Receives: Device: Mechanical Stimulation using whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean increase in the bone turnover marker Pro-collagen type 1 N-terminal propeptide (P1NP) between children born to antenatally vitamin D replete mothers versus antenatally vitamin D deficient mothers.
Measured: 2 years
Secondary outcomes (3)
Change in C-terminal cross-linked telopeptide of type I collagen(CTx)
Measured: 2 years
Change in Osteoprotegerin(OPG).
Measured: 2 years
Change in parathyroid hormone (PTH).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start19 May 2016
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, University of Southampton, University of Hull
- Responsible party
- Sponsor
- Investigators
- Sujatha Gopal, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743559
- Sponsor's protocol ID
- SCH/15/094
- Status last verified
- Jan 2020
- First submitted
- 5 Apr 2016
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Antenatal Vitamin D Supplementation Influence Bone's Postnatal Response to Mechanical Stimulation?
- ClinicalTrials.gov ID
- NCT02743559
- Acronym / sponsor ID
- SCH/15/094
- Conditions
- Vitamin D Deficiency, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield, University of Southampton, University of Hull
- Study start
- 19 May 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 19 Apr 2016 (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.
Fractures in children are common and the incidence is increasing. They are more common in children who have small, narrow and weak bones. Studies have shown that fractures in early childhood are associated with later bone strength.
There are several (i) non-modifiable (age, gender, race, genetics) and (ii) modifiable factors such as nutrition (vitamin D \& calcium intake) and exercise that can contribute to bone strength.
Low calcium is associated with an increased risk of fracture. Vitamin D plays a pivotal role in bone health by increasing the absorption of calcium from the gut. Investigators know from the previous research that there is a reduction in bone strength in children whose mothers had lower vitamin D levels during pregnancy.
Bone growth can also be achieved by loading of bone during childhood in the form of regular sport activities such as gymnastics and exercise programmes. Equally it can be achieved by using whole body vibration (WBV). WBV is the application of vibratory stimulus to the body in a synchronous fashion by which the bones are made much stronger reducing the risk of fracture in later life. Thus WBV can be used as a means to assess bone responsiveness to mechanical stimulation. Studies have shown that standing on a vibrating platform for 10 minutes a day can significantly increase the bone mass. Investigators' own research has also shown that healthy boys when made to stand on a vibration platform for 10 minutes daily for 5 days increased the strength and quality of their bones.
Thus the role of diet and mechanical loading are of considerable interest in determining their role in bone health and the prevention of fractures.
Maternal Vitamin D Osteoporosis Study (MAVIDOS) is a large study conducted recently at 3 different big centres (Sheffield, Southampton and Oxford). Results from this study have shown that giving a higher dose of vitamin D to pregnant women every day from 14 weeks of pregnancy increased the strength of the bones in their infants. In the proposed study Investigators aim to show how vitamin D supplementation during pregnancy affects the response of bone to vibration in children whose mothers participated in the MAVIDOS study in Sheffield. These children will be 4 years of age when they participate in this study.
The results of this study will help inform public health policy on vitamin D intake during pregnancy. This will also help the investigators identify a possible risk factor for poor bone health in children.
Detailed description
This project aims to determine whether antenatal vitamin D supplementation alters postnatal bone formation in response to mechanical stimulation.
The skeleton responds to mechanical stimulation by an increase in bone size and mass and that increment can persist into adult life and may lower the risk of osteoporosis (Daly, \& Bass, 2009). In contrast, without mechanical stimulation, bone is lost.
Cells within bone - osteoblasts and osteoclasts - are involved in the removal and formation of bone; the biomarkers Pro-collagen type 1 N-terminal propeptide (PINP) and C-terminal cross-linked telopeptide of type I collagen (CTx) are surrogates for their respective tissue level activities.
Whole body vibration (WBV) has been used as one of the methods to deliver mechanical stimulation in both adults and children.
The investigators have recently shown in healthy boys aged 9-11 years, WBV experienced 10 minutes daily for five days increases the P1NP by 25% and CTx by 11% (Harrison et al., 2015).
The investigators undertook another study recently to determine the effect of reduced vitamin D intake during pregnancy and early life on the skeleton's response to mechanical loading using a mouse model.
Our unpublished data show that antenatal vitamin D depletion substantially reduces the loading-dependent increase in both cortical and trabecular bone mass of offspring mice close to skeletal maturity.
The available human and mouse data suggest that antenatal vitamin D deficiency in some way influences the bone to become less responsive to mechanical stimulation.
The investigators are now ready to explore this in humans, to assess the responsiveness of the skeleton to mechanical stimulation by using WBV in the children who have been exposed to higher levels of vitamin D in-utero through maternal supplementation of vitamin D.
Through this study the investigators will be able to determine whether the in-utero environment can be modified easily to improve the skeletal responsiveness to activity and this improved skeletal health in the short and long term.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Active comparator | Device: Mechanical Stimulation using whole body vibrationChildren born to mothers who received vitamin D during pregnancy will undergo mechanical stimulation using whole body vibration(WBV) by standing on the vibration platform(LivMd) for 10 minutes on 5 consecutive mornings, at 7.30-8 am. |
| Placebo group | Placebo comparator | Device: Mechanical Stimulation using whole body vibrationChildren born to mothers who received placebo during pregnancy will also undergo mechanical stimulation using whole body vibration(WBV) by standing on the vibration platform (LivMd) for 10 minutes on 5 consecutive mornings, at 7.30-8 am. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children born to mothers who participated in MAVIDOS trial in Sheffield free from any condition affecting bone health, general nutrition, growth and glucose metabolism will be invited to enrol in the study.
Key exclusion criteria (2 listed)
- Children with (1) balance problems, (2) current or healing fractures (3) any chronic illness involving the bone, liver and kidney (4) current long-term use of steroids, anticonvulsants or any medication that might affect calcium and vitamin D metabolism will be identified from through a questionnaire and excluded.
- Participants will fill in questionnaires to estimate their calcium intake and Vitamin D exposure and this will be included in the analysis
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 |
|---|---|---|
| Mechanical Stimulation using whole body vibrationAll participants will undergo whole body vibration (WBV) by standing on the LivMD WBV platform on 5 consecutive mornings | Device | Placebo group, Vitamin D group |
Primary outcome
Difference in mean increase in the bone turnover marker Pro-collagen type 1 N-terminal propeptide (P1NP) between children born to antenatally vitamin D replete mothers versus antenatally vitamin D deficient mothers.
Time frame: 2 years
3 secondary outcomes
Change in C-terminal cross-linked telopeptide of type I collagen(CTx)
Time frame: 2 years
Change in Osteoprotegerin(OPG).
Time frame: 2 years
Change in parathyroid hormone (PTH).
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Sujatha Gopal principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Stimulation using whole body vibration in people with Vitamin D Deficiency and Osteoporosis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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: withdrawn, as of the sponsor's last update on 7 Jan 2020. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Difference in mean increase in the bone turnover marker Pro-collagen type 1 N-terminal propeptide (P1NP) between children born to antenatally vitamin D replete mothers versus antenatally vitamin D deficient mothers. (time frame: 2 years). 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 7 Jan 2020.