HealthyNCT01180946
Vitamin D Deficiency in Adolescent Girls
A study testing ergocalciferol in people with Healthy and Vitamin D Deficiency, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in adolescent girls and how these levels vary with other hormonal measurements. Read more about this study
- Who is it for?
- Ages 9 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Vitamin D Deficiency
- What is being tested?
- ergocalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Apr 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 9 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy girls aged 9-18 years
Who cannot join
- significant cardiac, hepatic, oncologic, or psychiatric disease
- a history of malabsorption, kidney stones, hypoparathyroidism, or growth hormone deficiency
- pregnancy
- diabetes mellitus
- BMI>/= 99th percentile for age and sex
- fracture within the preceding 3 months
Show all 11Show fewer
- hypogonadism (no pubertal development by age 12, absence of menarche by age 14)
- serum calcium <8 mg/dl or >11 mg/dl
- radiographic evidence of rickets
- use of medications know to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin D (>1000 units per day), excessive doses of vitamin D (>20,000 units/day), calcitriol, growth hormone, or anti-convulsants.
- use of hormonal birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in adolescent girls and how these levels vary with other hormonal measurements. We will also be looking at whether vitamin D supplementation in adolescents who are deficient in vitamin D alters the levels of FGF23 and other factors including insulin resistance.
Read the detailed description
Fibroblast growth factor 23 (FGF23) is a newly discovered hormone. Its primary function is to regulate phosphate metabolism, which it does both by directly regulating phosphate excretion through the kidney as well as by regulating vitamin D activity. What controls FGF23 levels is still under investigation; potential factors include dietary phosphate intake and vitamin D levels.
In this pilot study, we aim to investigate what the normal levels of FGF23 are in healthy girls and how these are related to other measurements of bone and mineral metabolism. Since vitamin D deficiency is very common in healthy girls, we expect a subset of the subjects in this study to be vitamin D deficient. We will then randomize these girls to vitamin D repletion or placebo and follow changes in FGF23 levels. Vitamin D deficiency has also been implicated in insulin resistance which is a precursor to diabetes. We will therefore also look at changes in insulin resistance with vitamin D repletion.
- Conditions
- Healthy, Vitamin D Deficiency
- Being tested
- ergocalciferol, placebo pill
- Keywords
- FGF23, FGF-23, vitamin D, vitamin D deficiency, insulin resistance, Healthy volunteers
- Medical subject headings
- Vitamin D Deficiency, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergocalciferolDietary supplement
Also called vitamin D
ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.
placebo pillOther
placebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion
| Study group | Role | What they receive |
|---|---|---|
| Ergocalciferol | Active comparator | Weekly ergocalciferol for 16 weeks Receives: Dietary Supplement: ergocalciferol |
| Placebo | Placebo comparator | Placebo pill. Note that all subjects in this arm will receive vitamin D repletion at the conclusion of the study. Receives: Other: placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in FGF23 level with vitamin D repletion
Measured: baseline and 16 weeks
Secondary outcomes (3)
change in bone turnover markers with vitamin D repletion
Measured: baseline and 16 weeks
change in mineral metabolism factors with vitamin D repletion
Measured: baseline and 16 weeks
change in insulin sensitivity with vitamin D repletion
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherri-Ann M. Burnett-Bowie, Massachusetts General Hospital
- Investigators
- Sherri-Ann Burnett-Bowie, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180946
- Sponsor's protocol ID
- 2010-P-001126/1
- Status last verified
- Nov 2013
- First submitted
- 11 Aug 2010
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burnett-Bowie SM, Henao MP, Dere ME, Lee H, Leder BZ. Effects of hPTH(1-34) infusion on circulating serum phosphate, 1,25-dihydroxyvitamin D, and FGF23 levels in healthy men. J Bone Miner Res. 2009 Oct;24(10):1681-5. doi: 10.1359/jbmr.090406.
PubMed 19419295Burnett-Bowie SM, Mendoza N, Leder BZ. Effects of gonadal steroid withdrawal on serum phosphate and FGF-23 levels in men. Bone. 2007 Apr;40(4):913-8. doi: 10.1016/j.bone.2006.10.016. Epub 2006 Dec 8.
PubMed 17157573Burnett SM, Gunawardene SC, Bringhurst FR, Juppner H, Lee H, Finkelstein JS. Regulation of C-terminal and intact FGF-23 by dietary phosphate in men and women. J Bone Miner Res. 2006 Aug;21(8):1187-96. doi: 10.1359/jbmr.060507.
PubMed 16869716Mitchell DM, Juppner H, Burnett-Bowie SM. FGF23 Is Not Associated With Age-Related Changes in Phosphate, but Enhances Renal Calcium Reabsorption in Girls. J Clin Endocrinol Metab. 2017 Apr 1;102(4):1151-1160. doi: 10.1210/jc.2016-4038.
PubMed 28323960
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency in Adolescent Girls
- ClinicalTrials.gov ID
- NCT01180946
- Acronym / sponsor ID
- 2010-P-001126/1
- Conditions
- Healthy, Vitamin D Deficiency
- Keywords
- FGF23, FGF-23, vitamin D, vitamin D deficiency, insulin resistance, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Aug 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.
Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in adolescent girls and how these levels vary with other hormonal measurements. We will also be looking at whether vitamin D supplementation in adolescents who are deficient in vitamin D alters the levels of FGF23 and other factors including insulin resistance.
Detailed description
Fibroblast growth factor 23 (FGF23) is a newly discovered hormone. Its primary function is to regulate phosphate metabolism, which it does both by directly regulating phosphate excretion through the kidney as well as by regulating vitamin D activity. What controls FGF23 levels is still under investigation; potential factors include dietary phosphate intake and vitamin D levels.
In this pilot study, we aim to investigate what the normal levels of FGF23 are in healthy girls and how these are related to other measurements of bone and mineral metabolism. Since vitamin D deficiency is very common in healthy girls, we expect a subset of the subjects in this study to be vitamin D deficient. We will then randomize these girls to vitamin D repletion or placebo and follow changes in FGF23 levels. Vitamin D deficiency has also been implicated in insulin resistance which is a precursor to diabetes. We will therefore also look at changes in insulin resistance with vitamin D repletion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergocalciferol | Active comparator | Dietary Supplement: ergocalciferolWeekly ergocalciferol for 16 weeks |
| Placebo | Placebo comparator | Other: placebo pillPlacebo pill. Note that all subjects in this arm will receive vitamin D repletion at the conclusion of the study. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- healthy girls aged 9-18 years
Key exclusion criteria (11 listed)
- significant cardiac, hepatic, oncologic, or psychiatric disease
- a history of malabsorption, kidney stones, hypoparathyroidism, or growth hormone deficiency
- pregnancy
- diabetes mellitus
- BMI>/= 99th percentile for age and sex
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 |
|---|---|---|
| ergocalciferolAlso: vitamin Dergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks. | Dietary supplement | Ergocalciferol |
| placebo pillplacebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion | Other | Placebo |
Primary outcome
change in FGF23 level with vitamin D repletion
Time frame: baseline and 16 weeks
3 secondary outcomes
change in bone turnover markers with vitamin D repletion
Time frame: baseline and 16 weeks
change in mineral metabolism factors with vitamin D repletion
Time frame: baseline and 16 weeks
change in insulin sensitivity with vitamin D repletion
Time frame: baseline and 16 weeks
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 5 Nov 2013.
- Background: PubMed 19419295Burnett-Bowie SM, Henao MP, Dere ME, Lee H, Leder BZ. Effects of hPTH(1-34) infusion on circulating serum phosphate, 1,25-dihydroxyvitamin D, and FGF23 levels in healthy men. J Bone Miner Res. 2009 Oct;24(10):1681-5. doi: 10.1359/jbmr.090406.
- Background: PubMed 17157573Burnett-Bowie SM, Mendoza N, Leder BZ. Effects of gonadal steroid withdrawal on serum phosphate and FGF-23 levels in men. Bone. 2007 Apr;40(4):913-8. doi: 10.1016/j.bone.2006.10.016. Epub 2006 Dec 8.
- Background: PubMed 16869716Burnett SM, Gunawardene SC, Bringhurst FR, Juppner H, Lee H, Finkelstein JS. Regulation of C-terminal and intact FGF-23 by dietary phosphate in men and women. J Bone Miner Res. 2006 Aug;21(8):1187-96. doi: 10.1359/jbmr.060507.
- Derived from this study: PubMed 28323960Mitchell DM, Juppner H, Burnett-Bowie SM. FGF23 Is Not Associated With Age-Related Changes in Phosphate, but Enhances Renal Calcium Reabsorption in Girls. J Clin Endocrinol Metab. 2017 Apr 1;102(4):1151-1160. doi: 10.1210/jc.2016-4038.
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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.
Sherri-Ann Burnett-Bowie, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ergocalciferol in people with Healthy and Vitamin D Deficiency, run by Massachusetts General Hospital at 1 site in United States.
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 11 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 5 Nov 2013. 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 States. 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 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?
change in FGF23 level with vitamin D repletion (time frame: baseline and 16 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 NCT01180946, which also lists 4 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 5 Nov 2013.