Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A Pilot Project.
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|ClinicalTrials.gov Identifier: NCT02233322|
Recruitment Status : Recruiting
First Posted : September 8, 2014
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autosomal Dominant Hypophosphatemic Rickets||Dietary Supplement: Iron||Not Applicable|
Iron will be provided in an open label treatment to all enrolled subjects. Iron levels will be monitored in blood and doses adjusted with the target of getting the iron levels to or a little above 100 mcg/dl.
The study will look to see if there is a decrease of FGF23 level. It will also look at how long does it take to decrease the level of FGF 23 and how long it takes for the serum and urine phosphate to normalize.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A Pilot|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: iron supplements
all subjects will receive iron supplementation based on iron levels in blood
Dietary Supplement: Iron
All subjects will receive iron supplementation based on iron levels in the blood
- Does increasing serum iron concentrations above 100 mcg/dl in patients with ADHR result in a decrease in intact FGF23. [ Time Frame: FGF23 will be measured at 1, 2, 3, 6, 9, and 12 months ]Perform a pilot study in ADHR patients with low serum iron concentrations (defined below) to determine if increasing serum iron concentrations above 100 mcg/dl results in a decrease in intact FGF23 (primary endpoint) and C-terminal FGF23 concentrations by at least 20% and normalizes serum phosphorus and TMP/GFR (tubular maximum phosphate reabsorption/ glomerular filtration rate) within 6 months of attaining goal iron concentrations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233322
|Contact: Marian D Hart, BSN, RNfirstname.lastname@example.org|
|Contact: Connie Sullivan, BSN, RNemail@example.com|
|United States, Indiana|
|Indiana University School of Medicine||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Marian D Hart, B.S.N., R.N. 317-948-8346 firstname.lastname@example.org|
|Contact: Connie Sullivan, B.S.N., R.N 317-944-8431 email@example.com|
|Principal Investigator: Michael Econs, M.D.|
|Sub-Investigator: Erik A Imel, M.D.|
|Sub-Investigator: Rakesh Mehta, M.D.|
|Principal Investigator:||Michael Econs, M.D.||Indiana University School of Medicine|