- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04629534
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study (MoMO PIP)
February 17, 2023 updated by: Raechel Irons, Medical University of South Carolina
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.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- MUSC Shawn Jenkins Childrens Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
|
Mothers in experimental group will receive 6,000 IU of vitamin D in addition to their prenatal vitamin, daily for 3 months.
Infants in this group will receive placebo vitamin D drops
Other Names:
|
Placebo Comparator: Group B
|
Mothers in placebo control group will receive 600 IU of vitamin D in the form of their prenatal vitamin along with placebo vitamin D. Infants of the mothers in this group will receive standard 400 IU of vitamin D
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Infants With Sufficient 25(OH)D Stores at 3 Months
Time Frame: 3 months post enrollment
|
Number of infants with 25(OH)D levels > 20 ng/mL
|
3 months post enrollment
|
Number of Mothers With Sufficient 25(OH)D Stores at 3 Months
Time Frame: 3 months post enrollment
|
Number of mothers with 25(OH)D levels >20 ng/mL
|
3 months post enrollment
|
Number of Mothers With Elevated Calcium Concentrations at 1 Month
Time Frame: 1 month post enrollment
|
Number of mothers with serum calcium > 10.5 mg/dL
|
1 month post enrollment
|
Number of Mothers With Elevated Calcium Concentrations at Month 2
Time Frame: 2 months post enrollment
|
Number of mothers with serum calcium > 10.5 mg/dL
|
2 months post enrollment
|
Number of Mothers With Elevated Calcium Concentrations at Month 3
Time Frame: 3 months post enrollment
|
Number of mothers with serum calcium > 10.5 mg/dL
|
3 months post enrollment
|
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1
Time Frame: 1 month post enrollment
|
Number of mothers with serum calcium > 1.0 mmol/mmol
|
1 month post enrollment
|
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2
Time Frame: 2 months post enrollment
|
Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol
|
2 months post enrollment
|
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3
Time Frame: 3 months post enrollment
|
Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol
|
3 months post enrollment
|
Number of Infants With Elevated Calcium Concentration at Month 1
Time Frame: 1 month post enrollment
|
Number of infants with serum calcium > 11.0 mg/dL
|
1 month post enrollment
|
Number of Infants With Elevated Calcium Concentration at Month 2
Time Frame: 2 months post enrollment
|
Number of infants with serum calcium > 11.0 mg/dL
|
2 months post enrollment
|
Number of Infants With Elevated Calcium Concentration at Month 3
Time Frame: 3 months post enrollment
|
Number of infants with serum calcium > 11.0 mg/dL
|
3 months post enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Raechel Irons, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
November 10, 2020
First Submitted That Met QC Criteria
November 10, 2020
First Posted (Actual)
November 16, 2020
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
February 17, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00099911
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin D Deficiency
-
University Hospital, Clermont-FerrandTerminated
-
Rajavithi HospitalQueen Sirikit National Institute of Child HealthCompleted
-
Universidade de Passo FundoUnknownDeficiency, Vitamin DBrazil
-
Federal University of Rio Grande do SulCompletedDeficiency, Vitamin DBrazil
-
Nutrition Institute, SloveniaEuropean Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.CompletedVitamin B 12 Deficiency | Vitamin d Deficiency | Protein DeficiencySlovenia
-
Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionCompletedElderly, Frail | Deficiency, Vitamin DNetherlands
-
University of PaviaIstituti Clinici Scientifici Maugeri SpAUnknownVitamin D Deficiency | Vitamin D3 Deficiency | Vitamin DItaly
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingVitamin d DeficiencyChina
-
Okan UniversityArçelik A.Ş.Completed
-
Brigham and Women's HospitalCompletedVitamin d Deficiency
Clinical Trials on High dose Cholecalciferol
-
Mansoura University Children HospitalCompletedPrematurity | Late-onset SepsisEgypt
-
National Institute of Allergy and Infectious Diseases...Autoimmunity Centers of ExcellenceTerminatedSystemic Lupus ErythematosusUnited States
-
Mayo ClinicCompletedHealthy VolunteersUnited States
-
Beijing Northland Biotech. Co., Ltd.CompletedAcute Myocardial InfarctionChina
-
National Institute of Diabetes and Digestive and...Washington University School of Medicine; University of Alabama at Birmingham; Icahn School of Medicine at Mount Sinai and other collaboratorsCompletedEnd Stage Renal DiseaseUnited States
-
MedImmune LLCCompletedNon-alcoholic Fatty Liver Disease (NAFLD) | Non-alcoholic Steatohepatitis (NASH)United States, Puerto Rico
-
University of MichiganCrohn's and Colitis FoundationTerminatedVitamin D Deficiency | Crohn's DiseaseUnited States
-
Beijing Northland Biotech. Co., Ltd.CompletedSafety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.InfarctionAcute Myocardial InfarctionChina
-
Federal University of ParaíbaUnknown
-
Baylor College of MedicineNeuroMetrix, Inc.RecruitingPain | Neuropathy | Chemotherapy-induced Peripheral NeuropathyUnited States