Nutritional RicketsPhase 4NCT00949832
Vitamin D and Genetics in Nutritional Rickets
A Phase 4 study testing Vitamin D + Calcium, Calcium and Vitamin D2 in people with Nutritional Rickets, run by Mayo Clinic at 1 site in Nigeria.
Trial summary
The purpose of this study is: 1. To compare the response of rickets to calcium with and without vitamin D. 2. To assess whether vitamin D increases calcium absorption in calcium deficiency rickets. 3. To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2 4. Read more about this study
- Who is it for?
- Ages 6 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Rickets
- What is being tested?
- Vitamin D + Calcium, Calcium and Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteNigeria
- Study dates
- Jan 2004to Apr 2007
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical features of rickets
- Active rickets on X-ray
Who cannot join
- Treatment with calcium or vitamin D in preceding 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is:
- To compare the response of rickets to calcium with and without vitamin D.
- To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.
- To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2
- To identify mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh.
- To assess the functional status of the 25-hydroxylase enzyme in families possessing a 25-hydroxylase mutation.
Read the detailed description
Previous studies of Nigerian children with rickets demonstrated the superiority of calcium over vitamin D in producing healing. It is not known whether the addition of vitamin D to calcium will produce a better response to treatment than calcium alone in Nigerian children. A previous study suggested the possibility that vitamin D may augment the effect of calcium. We will compare the response of rickets to calcium with and without vitamin D. In addition, very little human data clearly demonstrates the effect of supplemental vitamin D on calcium absorption. We will assess whether oral vitamin D increases the already high calcium absorption even further.
Recent published data indicate that the increase in serum 25-hydroxyvitamin D may be more sustained with vitamin D3 than with vitamin D2. We will compare the response of Nigerian children with and without rickets to orally administered vitamin D3 and vitamin D2.
Because nutritional rickets tends to run in families, we will also examine amplified DNA for evidence of mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh. Families possessing a recently identified 25-hydroxylase mutation will be given oral vitamin D2 and vitamin D3 to determine the functional status of the 25-hydroxylase enzyme.
- Conditions
- Nutritional Rickets
- Being tested
- Vitamin D + Calcium, Calcium, Vitamin D2, Vitamin D3
- Keywords
- rickets, calcium, vitamin D, nutrition, child
- Medical subject headings
- Vitamin D Deficiency, Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D + CalciumDietary supplement
Also called ergocalciferol
Vitamin D 50,000 IU orally once monthly for 6 months; Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months
CalciumDietary supplement
Also called limestone
Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months; Vitamin B complex (used as placebo) 1 tablet monthly for 6 months
Vitamin D2Dietary supplement
Also called ergocalciferol
50,000 IU given orally once
Vitamin D3Dietary supplement
Also called cholecalciferol
Vitamin D3 50,000 IU given orally once
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D + Calcium | Active comparator | Vitamin D and calcium supplementation Receives: Dietary Supplement: Vitamin D + Calcium |
| Calcium | Placebo comparator | Calcium supplementation Receives: Dietary Supplement: Calcium |
| Vitamin D2 | Active comparator | Vitamin D2 response Receives: Dietary Supplement: Vitamin D2 |
| Vitamin D3 | Active comparator | Vitamin D3 response Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
XR healing of rickets
Measured: 6 months
Secondary outcomes (5)
Alkaline phosphatase
Measured: 6 months
Serum calcium
Measured: 6 months
25-hydroxyvitamin D
Measured: 6 months
1,25-dihydroxyvitamin D
Measured: 2 weeks
Calcium absorption
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJan 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nutritional RicketsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Jos University Teaching Hospital
- Investigators
- Thomas D Thacher, MD, Principal investigator, Mayo Clinic, Jos University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949832
- Sponsor's protocol ID
- 07-006041
- Status last verified
- Jul 2012
- First submitted
- 29 Jul 2009
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Thacher TD, Fischer PR, Pettifor JM, Lawson JO, Isichei CO, Reading JC, Chan GM. A comparison of calcium, vitamin D, or both for nutritional rickets in Nigerian children. N Engl J Med. 1999 Aug 19;341(8):563-8. doi: 10.1056/NEJM199908193410803.
PubMed 10451461Graff M, Thacher TD, Fischer PR, Stadler D, Pam SD, Pettifor JM, Isichei CO, Abrams SA. Calcium absorption in Nigerian children with rickets. Am J Clin Nutr. 2004 Nov;80(5):1415-21. doi: 10.1093/ajcn/80.5.1415.
PubMed 15531695Thacher TD, Fischer PR, Isichei CO, Pettifor JM. Early response to vitamin D2 in children with calcium deficiency rickets. J Pediatr. 2006 Dec;149(6):840-4. doi: 10.1016/j.jpeds.2006.08.070.
PubMed 17137904Fischer PR, Thacher TD, Pettifor JM, Jorde LB, Eccleshall TR, Feldman D. Vitamin D receptor polymorphisms and nutritional rickets in Nigerian children. J Bone Miner Res. 2000 Nov;15(11):2206-10. doi: 10.1359/jbmr.2000.15.11.2206.
PubMed 11092401Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
PubMed 33305842Thacher TD, Fischer PR, Pettifor JM. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial. Arch Dis Child. 2014 Sep;99(9):807-11. doi: 10.1136/archdischild-2013-305275. Epub 2014 Apr 19.
PubMed 24748637
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Genetics in Nutritional Rickets
- ClinicalTrials.gov ID
- NCT00949832
- Acronym / sponsor ID
- 07-006041
- Conditions
- Nutritional Rickets
- Keywords
- rickets, calcium, vitamin D, nutrition, child
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Jos University Teaching Hospital
- Study start
- Jan 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 30 Jul 2009 (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.
The purpose of this study is:
- To compare the response of rickets to calcium with and without vitamin D.
- To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.
- To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2
- To identify mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh.
- To assess the functional status of the 25-hydroxylase enzyme in families possessing a 25-hydroxylase mutation.
Detailed description
Previous studies of Nigerian children with rickets demonstrated the superiority of calcium over vitamin D in producing healing. It is not known whether the addition of vitamin D to calcium will produce a better response to treatment than calcium alone in Nigerian children. A previous study suggested the possibility that vitamin D may augment the effect of calcium. We will compare the response of rickets to calcium with and without vitamin D. In addition, very little human data clearly demonstrates the effect of supplemental vitamin D on calcium absorption. We will assess whether oral vitamin D increases the already high calcium absorption even further.
Recent published data indicate that the increase in serum 25-hydroxyvitamin D may be more sustained with vitamin D3 than with vitamin D2. We will compare the response of Nigerian children with and without rickets to orally administered vitamin D3 and vitamin D2.
Because nutritional rickets tends to run in families, we will also examine amplified DNA for evidence of mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh. Families possessing a recently identified 25-hydroxylase mutation will be given oral vitamin D2 and vitamin D3 to determine the functional status of the 25-hydroxylase enzyme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D + Calcium | Active comparator | Dietary Supplement: Vitamin D + CalciumVitamin D and calcium supplementation |
| Calcium | Placebo comparator | Dietary Supplement: CalciumCalcium supplementation |
| Vitamin D2 | Active comparator | Dietary Supplement: Vitamin D2Vitamin D2 response |
| Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3Vitamin D3 response |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical features of rickets
- Active rickets on X-ray
Key exclusion criteria (1 listed)
- Treatment with calcium or vitamin D in preceding 30 days
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 + CalciumAlso: ergocalciferolVitamin D 50,000 IU orally once monthly for 6 months; Calcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months | Dietary supplement | Vitamin D + Calcium |
| CalciumAlso: limestoneCalcium carbonate (as powdered limestone) 500 mg orally twice daily for 6 months; Vitamin B complex (used as placebo) 1 tablet monthly for 6 months | Dietary supplement | Calcium |
| Vitamin D2Also: ergocalciferol50,000 IU given orally once | Dietary supplement | Vitamin D2 |
| Vitamin D3Also: cholecalciferolVitamin D3 50,000 IU given orally once | Dietary supplement | Vitamin D3 |
Primary outcome
XR healing of rickets
Time frame: 6 months
5 secondary outcomes
Alkaline phosphatase
Time frame: 6 months
Serum calcium
Time frame: 6 months
25-hydroxyvitamin D
Time frame: 6 months
1,25-dihydroxyvitamin D
Time frame: 2 weeks
Calcium absorption
Time frame: 1 week
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 4 Jul 2012.
- Background: PubMed 10451461Thacher TD, Fischer PR, Pettifor JM, Lawson JO, Isichei CO, Reading JC, Chan GM. A comparison of calcium, vitamin D, or both for nutritional rickets in Nigerian children. N Engl J Med. 1999 Aug 19;341(8):563-8. doi: 10.1056/NEJM199908193410803.
- Background: PubMed 15531695Graff M, Thacher TD, Fischer PR, Stadler D, Pam SD, Pettifor JM, Isichei CO, Abrams SA. Calcium absorption in Nigerian children with rickets. Am J Clin Nutr. 2004 Nov;80(5):1415-21. doi: 10.1093/ajcn/80.5.1415.
- Background: PubMed 17137904Thacher TD, Fischer PR, Isichei CO, Pettifor JM. Early response to vitamin D2 in children with calcium deficiency rickets. J Pediatr. 2006 Dec;149(6):840-4. doi: 10.1016/j.jpeds.2006.08.070.
- Background: PubMed 11092401Fischer PR, Thacher TD, Pettifor JM, Jorde LB, Eccleshall TR, Feldman D. Vitamin D receptor polymorphisms and nutritional rickets in Nigerian children. J Bone Miner Res. 2000 Nov;15(11):2206-10. doi: 10.1359/jbmr.2000.15.11.2206.
- Derived from this study: PubMed 33305842Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Derived from this study: PubMed 24748637Thacher TD, Fischer PR, Pettifor JM. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial. Arch Dis Child. 2014 Sep;99(9):807-11. doi: 10.1136/archdischild-2013-305275. Epub 2014 Apr 19.
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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.
Thomas D Thacher, MD principal investigator
Mayo Clinic, Jos University Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D + Calcium, Calcium and Vitamin D2 in people with Nutritional Rickets, run by Mayo Clinic at 1 site in Nigeria.
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 1 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 4 Jul 2012. 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 Nigeria. 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.
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?
XR 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?
On the ClinicalTrials.gov record for NCT00949832, which also lists 6 linked publications.
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 4 Jul 2012.