Nutritional RicketsPhase 4ROCAVINRNCT01578434
Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
A Phase 4 study testing Vitamin D, Calcium Carbonate and Vitamin D and Calcium in people with Nutritional Rickets, run by Lady Hardinge Medical College.
Trial summary
Rickets, a common nutritional disorder, is usually considered to be due to vitamin D deficiency. However, in the last few decades many studies have shown that in tropical countries, with abundance of sunshine, calcium deficiency may play a more important role in the causation of rickets. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Rickets
- What is being tested?
- Vitamin D, Calcium Carbonate and Vitamin D and Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Apr 2009
- Phase
- Phase 4
- 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 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 6 months to 5 years with rickets
Who cannot join
- Non nutritional cause of rickets
- taken vitamin D or calcium supplements in last 6 months
- children presenting with convulsions
About this study
Rickets, a common nutritional disorder, is usually considered to be due to vitamin D deficiency. However, in the last few decades many studies have shown that in tropical countries, with abundance of sunshine, calcium deficiency may play a more important role in the causation of rickets. Studies from adults in India have also shown that calcium intake of our population is much below the recommended allowance. The calcium deficiency gets compounded by the high level of phytates in the conventional vegetarian diet consumed by the majority of the population. There are few studies on children in India / other Asian countries on assessment of dietary calcium intake.
However, recent studies from many nations of the world have also shown a wide spread prevalence of vitamin D deficiency in adolescent and adult population. A study done at our own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and their infants.
Read more
Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not clear what plays a more important role in the etiology of rickets in India or other Asian countries.
The present study is therefore planned with the following objectives:
- To study the dietary calcium intake, sun exposure and serum vitamin D levels in children with and without rickets.
- To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the treatment of nutritional rickets.
- Conditions
- Nutritional Rickets
- Being tested
- Vitamin D, Calcium Carbonate, Vitamin D and Calcium
- Keywords
- Nutritional Rickets, Calcium, Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D: 6 lakh IU single im dose Calcium: 75 mg/kg calcium daily for 3 months vitamin D and Calcium: combination of above two
Calcium CarbonateDrug
Calcium: 75 mg/kg calcium daily for 3 months
Vitamin D and CalciumDrug
Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Calcium Carbonate | Active comparator | Calcium: 75 mg/kg calcium daily for 3 months Receives: Drug: Calcium Carbonate |
| Vitamin D | Active comparator | Vitamin D: 6 lakh IU single im dose Receives: Drug: Vitamin D |
| Vitamin D and Calcium | Active comparator | vitamin D and Calcium: combination of above two Receives: Drug: Vitamin D and Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of rickets
Assessment of healing of rickets on biochemical and radiological assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startNov 2007
- Primary completionFeb 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional RicketsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Varun, Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578434
- Sponsor's protocol ID
- rickets 1
- Acronym
- ROCAVINR
- Status last verified
- Apr 2012
- First submitted
- 12 Apr 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Calcium And Vitamin D In Nutritional Rickets And It's Management
- ClinicalTrials.gov ID
- NCT01578434
- Acronym / sponsor ID
- ROCAVINR / rickets 1
- Conditions
- Nutritional Rickets
- Keywords
- Nutritional Rickets, Calcium, Vitamin D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Nov 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Apr 2012 (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.
Rickets, a common nutritional disorder, is usually considered to be due to vitamin D deficiency. However, in the last few decades many studies have shown that in tropical countries, with abundance of sunshine, calcium deficiency may play a more important role in the causation of rickets. Studies from adults in India have also shown that calcium intake of our population is much below the recommended allowance. The calcium deficiency gets compounded by the high level of phytates in the conventional vegetarian diet consumed by the majority of the population. There are few studies on children in India / other Asian countries on assessment of dietary calcium intake.
However, recent studies from many nations of the world have also shown a wide spread prevalence of vitamin D deficiency in adolescent and adult population. A study done at our own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and their infants.
Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not clear what plays a more important role in the etiology of rickets in India or other Asian countries.
The present study is therefore planned with the following objectives:
- To study the dietary calcium intake, sun exposure and serum vitamin D levels in children with and without rickets.
- To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the treatment of nutritional rickets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calcium Carbonate | Active comparator | Drug: Calcium CarbonateCalcium: 75 mg/kg calcium daily for 3 months |
| Vitamin D | Active comparator | Drug: Vitamin DVitamin D: 6 lakh IU single im dose |
| Vitamin D and Calcium | Active comparator | Drug: Vitamin D and Calciumvitamin D and Calcium: combination of above two |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 6 months to 5 years with rickets
Key exclusion criteria (3 listed)
- Non nutritional cause of rickets
- taken vitamin D or calcium supplements in last 6 months
- children presenting with convulsions
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: 6 lakh IU single im dose Calcium: 75 mg/kg calcium daily for 3 months vitamin D and Calcium: combination of above two | Drug | Vitamin D |
| Calcium CarbonateCalcium: 75 mg/kg calcium daily for 3 months | Drug | Calcium Carbonate |
| Vitamin D and CalciumVitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months | Drug | Vitamin D and Calcium |
Primary outcome
Healing of rickets
Time frame: 6 months
Assessment of healing of rickets on biochemical and radiological assessment
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 19 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D, Calcium Carbonate and Vitamin D and Calcium in people with Nutritional Rickets, run by Lady Hardinge Medical College.
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 3 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 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Healing of rickets (time frame: 6 months). 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 19 Apr 2012.