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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date February 2023
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
High dose 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
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

Locations

Country Name City State
United States MUSC Shawn Jenkins Childrens Hospital Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

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
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