Vitamin D Deficiency Clinical Trial
— MoMO PIPOfficial title:
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP): Maternal Diet and Vitamin D Supplementation Effects on Preterm Infants, a Randomized Control Pilot Study.
NCT number | NCT04629534 |
Other study ID # | 00099911 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 6, 2021 |
Est. completion date | April 1, 2022 |
Verified date | February 2023 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet education. The central hypothesis is that by maximizing maternal vitamin D status in breastfed, preterm infants (<35 weeks), there will be an increase infant 25(OH)D status at 1,2, and 3 months of age.
Status | Terminated |
Enrollment | 8 |
Est. completion date | April 1, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Days to 45 Years |
Eligibility | Inclusion Criteria: - Women with documentation of fully breastfeeding who present within one month of delivery, who are 18-45 years old and in good general health will be eligible for participation. - Infants <35 weeks corrected gestational age at birth Exclusion Criteria: - NO DMI/DMII, HTN, or parathyroid disease IF thyroid issues, currently euthyroid - Multiple gestations - No liver disease - No major congenital abnormalities - No kidney disease - No inborn errors of metabolism - No parathyroid disease - No disorders of calcium metabolism - No antiepileptics - No steroids - No congenital heart disease - No severe illness at birth deemed incompatible with survival |
Country | Name | City | State |
---|---|---|---|
United States | MUSC Shawn Jenkins Childrens Hospital | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Infants With Sufficient 25(OH)D Stores at 3 Months | Number of infants with 25(OH)D levels > 20 ng/mL | 3 months post enrollment | |
Primary | Number of Mothers With Sufficient 25(OH)D Stores at 3 Months | Number of mothers with 25(OH)D levels >20 ng/mL | 3 months post enrollment | |
Primary | Number of Mothers With Elevated Calcium Concentrations at 1 Month | Number of mothers with serum calcium > 10.5 mg/dL | 1 month post enrollment | |
Primary | Number of Mothers With Elevated Calcium Concentrations at Month 2 | Number of mothers with serum calcium > 10.5 mg/dL | 2 months post enrollment | |
Primary | Number of Mothers With Elevated Calcium Concentrations at Month 3 | Number of mothers with serum calcium > 10.5 mg/dL | 3 months post enrollment | |
Primary | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1 | Number of mothers with serum calcium > 1.0 mmol/mmol | 1 month post enrollment | |
Primary | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2 | Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol | 2 months post enrollment | |
Primary | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3 | Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol | 3 months post enrollment | |
Primary | Number of Infants With Elevated Calcium Concentration at Month 1 | Number of infants with serum calcium > 11.0 mg/dL | 1 month post enrollment | |
Primary | Number of Infants With Elevated Calcium Concentration at Month 2 | Number of infants with serum calcium > 11.0 mg/dL | 2 months post enrollment | |
Primary | Number of Infants With Elevated Calcium Concentration at Month 3 | Number of infants with serum calcium > 11.0 mg/dL | 3 months post enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04244474 -
Effect of Vitamin D Supplementation on Improvement of Pneumonic Children
|
Phase 1/Phase 2 | |
Recruiting |
NCT05459298 -
ViDES Trial (Vitamin D Extra Supplementation)
|
N/A | |
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT04476511 -
The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules
|
Phase 3 | |
Completed |
NCT03920150 -
Vitamin D 24'000 IU for Oral Intermittent Supplementation
|
Phase 3 | |
Completed |
NCT03264625 -
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
|
Phase 2 | |
Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
Recruiting |
NCT05084248 -
Vitamin D Deficiency in Adults Following a Major Burn Injury
|
Phase 4 | |
Completed |
NCT05506696 -
Vitamin D Supplementation Study
|
N/A | |
Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
Completed |
NCT03234218 -
Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
|
||
Completed |
NCT02714361 -
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
N/A | |
Completed |
NCT03203382 -
Corneal Nerve Structure in Sjogren's
|
||
Completed |
NCT02906319 -
Vitamin D and HbA1c Levels in Diabetic Patients With CKD
|
N/A | |
Completed |
NCT02118129 -
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
|
N/A | |
Not yet recruiting |
NCT01419821 -
Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5
|
N/A | |
Completed |
NCT02275650 -
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
|
N/A | |
Completed |
NCT02187146 -
The Effects of Serum Vitamin D and IVF Outcome
|
N/A | |
Completed |
NCT01741181 -
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2
|
Phase 4 | |
Completed |
NCT01651000 -
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
|
Phase 3 |