Clinical trials: Malnutrition Pregnancy
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01704079
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- OPKO IP Holdings II, Inc.
Vitamin D Deficiency, Pre-Eclampsia
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3).
- Trial name
- NCT03101150
- Testing
- 400 IU Vitamin D3, 4000 IU Vitamin D3
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- King Fahad Medical City
Vitamin D Deficiency
Evaluation of Vitamin D Requirements During Pregnancy
The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester.
- Trial name
- NCT00292591
- Testing
- cholecalciferol (vitamin D3), cholecalciferol
- Where
- United States
- Volunteers
- 501 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Secondary Hyperparathyroidism
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving…
- Trial name
- NCT01576146
- Testing
- Etelcalcetide
- Volunteers
- 30 people
- Sponsor
- KAI Pharmaceuticals
Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.
- Conditions
- Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases
- Trial name
- NCT04019379
- Testing
- High Phosphorus Diet, Low Phosphorus Diet
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Minnesota
HIV, Metabolic Syndrome
Incidence of HANA Conditions in HIV-infected Individuals
With the availability of effective anti-retroviral therapy, HIV-infected individuals are expected not to die of AIDS and have longer life expectancy.
- Conditions
- HIV, Metabolic Syndrome, Osteopenia, Osteoporosis
- Trial name
- NCT03483584
- Where
- Hong Kong
- Volunteers
- 215 people
- Sponsor
- Chinese University of Hong Kong
X-Linked Hypophosphatemia
Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)
The primary objectives of this study are to: Assess the long-term safety of KRN23 subcutaneous (SC) administration in adult subjects with XLH Assess the proportion of subjects achieving serum phosphorus levels in the normal range…
- Trial name
- NCT02312687
- Testing
- KRN23
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Kyowa Kirin, Inc.
Osteoporosis, Renal Osteodystrophy
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function.
- Conditions
- Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications
- Trial name
- ProliaKTx (NCT03960554)
- Testing
- Denosumab Inj 60 mg/ml
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Thomas Nickolas, MD MS
X-Linked Hypophosphatemia
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
The primary objectives of the study are to: Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers…
- Trial name
- NCT02750618
- Testing
- Burosumab
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Kyowa Kirin, Inc.
Vitamin D Deficiency, End-stage Renal Disease
Impact of Vitamin D Repletion in Hemodialysis Patients
Dialysis patients often suffer from defects in their immune system (that part of the body which fights infection). Evidence suggests that Vitamin D deficiency may have a negative effect on immunity, and many dialysis patients are…
- Trial name
- NCT01175798
- Testing
- Cholecalciferol
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Mehrotra, Anita, M.D.
X-linked Hypophosphatemia
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).
- Trial name
- NCT02537431
- Testing
- burosumab
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- Kyowa Kirin, Inc.
Cardiovascular Disease, Chronic Kidney Disease
Vascular Risk After Kidney Transplantation
Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant.
- Conditions
- Cardiovascular Disease, Chronic Kidney Disease, Diabetes, Vitamin D Deficiency
- Trial name
- NCT00374595
- Where
- United States
- Volunteers
- 338 people
- Sponsor
- University of Nebraska
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01651000
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- OPKO IP Holdings II, Inc.
Emotional Disturbances, Depression
Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women
The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women.
- Conditions
- Emotional Disturbances, Depression, Pregnancy Late, Post-Partum Depression
- Trial name
- A-RCT (NCT03416010)
- Testing
- COPE-P
- Where
- 3 sites in United States
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Ohio State University
X-Linked Hypophosphatemia
Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).
- Trial name
- NCT02915705
- Testing
- burosumab, Oral Phosphate Supplement, active vitamin D
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin, Inc.
X-linked Hypophosphatemia, Hypophosphatemic Rickets
Calcitriol Monotherapy for X-Linked Hypophosphatemia
Children and adults with XLH recruited will be treated with calcitriol alone (without phosphate supplementation) for one year, during which the calcitriol dose will be escalated during the first 3 months of therapy.
- Conditions
- X-linked Hypophosphatemia, Hypophosphatemic Rickets, Hypophosphatemic Rickets, X-Linked Dominant
- Trial name
- NCT03748966
- Testing
- Calcitriol
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Massachusetts General Hospital
Polycystic Ovary Syndrome, Vitamin D Deficiency
The Effects of Vitamin D on Angiogenic Factors in Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS) affects 5 to 10% of women of reproductive age. It is characterized by a cluster of hyperandrogenism, hyperinsulinemia, menstrual dysfunction, hirsutism and infertility.
- Trial name
- NCT02460380
- Testing
- Vitamin D3
- Volunteers
- 93 people
- Sponsor
- Maimonides Medical Center
Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy
The Effect of Etelcalcetide on CKD-MBD
The proposed study will investigate the effects of etelcalcetide on the bone and blood-vessel health in patients with CKD-MBD. The investigators will test if etelcalcetide makes bone and blood-vessels healthier.
- Conditions
- Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy, Vascular Calcification, Hyperparathyroidism; Secondary, Renal
- Trial name
- Parsabiv-MBD (NCT03960437)
- Testing
- Etelcalcetide
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Thomas Nickolas, MD MS
Polycystic Ovarian Syndrome, Vitamin D Deficiency
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation in overweight (BMI > 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the…
- Trial name
- NCT00743574
- Testing
- Vitamin D2 (Ergocalciferol), Medroxyprogesterone (Provera), Vitamin D3 (Cholecalciferol)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Yale University