Vitamin D DeficiencyPhase 4MoMO PIPNCT04629534

Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study

A Phase 4 study testing High dose Cholecalciferol and Cholecalciferol in people with Vitamin D Deficiency and Nutritional Deficiency, run by Medical University of South Carolina at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 0 days to 45 years
Conditions the study is for: Vitamin D Deficiency, Nutritional Deficiency
What is being tested?: High dose Cholecalciferol and Cholecalciferol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 6 May 2021to 1 Apr 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 days to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

MUSC Shawn Jenkins Childrens Hospital
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official 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.

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.

Conditions: Vitamin D Deficiency, Nutritional Deficiency
Being tested: High dose Cholecalciferol, Cholecalciferol
Keywords: Vitamin D
Medical subject headings: Vitamin D Deficiency, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High dose CholecalciferolDrug
Also called 6,600 IU of cholecalciferol
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
CholecalciferolDrug
Also called 600 IU of cholecalciferol
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

Study groups in NCT04629534
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Drug: High dose Cholecalciferol
Group B	Placebo comparator	Not described Receives: Drug: Cholecalciferol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Infants With Sufficient 25(OH)D Stores at 3 Months
Number of infants with 25(OH)D levels > 20 ng/mL
Measured: 3 months post enrollment
Number of Mothers With Sufficient 25(OH)D Stores at 3 Months
Number of mothers with 25(OH)D levels >20 ng/mL
Measured: 3 months post enrollment
Number of Mothers With Elevated Calcium Concentrations at 1 Month
Number of mothers with serum calcium > 10.5 mg/dL
Measured: 1 month post enrollment
Number of Mothers With Elevated Calcium Concentrations at Month 2
Number of mothers with serum calcium > 10.5 mg/dL
Measured: 2 months post enrollment
Number of Mothers With Elevated Calcium Concentrations at Month 3
Number of mothers with serum calcium > 10.5 mg/dL
Measured: 3 months post enrollment
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1
Number of mothers with serum calcium > 1.0 mmol/mmol
Measured: 1 month post enrollment
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2
Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol
Measured: 2 months post enrollment
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3
Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol
Measured: 3 months post enrollment
Number of Infants With Elevated Calcium Concentration at Month 1
Number of infants with serum calcium > 11.0 mg/dL
Measured: 1 month post enrollment
Number of Infants With Elevated Calcium Concentration at Month 2
Number of infants with serum calcium > 11.0 mg/dL
Measured: 2 months post enrollment
Number of Infants With Elevated Calcium Concentration at Month 3
Number of infants with serum calcium > 11.0 mg/dL
Measured: 3 months post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 20211 Apr 2022

First posted16 Nov 2020
Study start6 May 2021
Primary completion31 Dec 2021
Study completion1 Apr 2022

Why it stopped: low enrollment, lack of funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04629534
Sponsor's protocol ID: 00099911
Acronym: MoMO PIP
Status last verified: Feb 2023
First submitted: 10 Nov 2020
Last updated: 15 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vitamin D Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT04629534
Acronym / sponsor ID: MoMO PIP / 00099911
Conditions: Vitamin D Deficiency, Nutritional Deficiency
Keywords: Vitamin D
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: low enrollment, lack of funding
Enrolment: 8 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 6 May 2021 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 1 Apr 2022 (actual)
First posted: 16 Nov 2020 (actual)
Results: Posted 15 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: High dose Cholecalciferol
Group B	Placebo comparator	Drug: Cholecalciferol

Who may qualify

Ages: 0 days to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (12 listed)

NO DMI/DMII, HTN, or parathyroid disease IF thyroid issues, currently euthyroid
Multiple gestations
No liver disease
No major congenital abnormalities
No kidney disease

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
High dose CholecalciferolAlso: 6,600 IU of cholecalciferolMothers 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	Drug	Group A
CholecalciferolAlso: 600 IU of cholecalciferolMothers 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	Drug	Group B

Primary outcome

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
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
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
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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 15 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	4	3
Group B	4	2

Primary outcome: Number of Infants With Sufficient 25(OH)D Stores at 3 Months

Time frame: 3 months post enrollment. Count of participants. Unit: Participants

Measure	Group A n = 1	Group B n = 1
Value	1	1

Primary outcome: Number of Mothers With Sufficient 25(OH)D Stores at 3 Months

Time frame: 3 months post enrollment. Count of participants. Unit: Participants

Measure	Group A n = 1	Group B n = 2
Value	1	1

Primary outcome: Number of Mothers With Elevated Calcium Concentrations at 1 Month

Time frame: 1 month post enrollment. Count of participants. Unit: Participants

Measure	Group A n = 1	Group B n = 2
Value	0	0

Primary outcome: Number of Mothers With Elevated Calcium Concentrations at Month 2

Time frame: 2 months post enrollment. Count of participants. Unit: Participants

Measure	Group A n = 1	Group B n = 2
Value	0	0

Adverse events

Time frame: Data was collected over a 3 month period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group B	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): Early termination leading to a small number of subjects analyzed with difficulty in enrollment. Technical issue with calculating total vitamin D intake through formula fortification and TPN along with the study drugs which can skew our data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Vitamin D Deficiency

RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia

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.

Raechel Irons, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 15 Mar 2023. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Infants With Sufficient 25(OH)D Stores at 3 Months (time frame: 3 months post enrollment). The study lists 11 primary outcomes in all. 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 NCT04629534.

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 15 Mar 2023.