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low enrollment, lack of funding
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose Cholecalciferol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Number of Mothers With Elevated Calcium Concentrations at 1 Month | Number of mothers with serum calcium > 10.5 mg/dL | 1 month post enrollment |
| Number of Mothers With Elevated Calcium Concentrations at Month 2 | Number of mothers with serum calcium > 10.5 mg/dL | 2 months post enrollment |
| Number of Mothers With Elevated Calcium Concentrations at Month 3 | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raechel Irons, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC Shawn Jenkins Childrens Hospital | Charleston | South Carolina | 29425 | United States |
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This study involves mother and infant dyads. There were 8 individual participants enrolled onto the study. 4 mothers and 4 infants which is equivalent to 4 dyads. Group A had 2 dyads (4 individual participants). Group B also had 2 dyads (4 individual participants) However, if an infant became ineligible but mother still qualified, she could remain in the study separately. The participant flow reflects the individual participants.
This study contained dyads of mother's and their newborn infants. Double-blinded control randomized study
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | 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 of these mothers will receive placebo drops. |
| FG001 | Group B | 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 these mothers will receive standard 400 IU of vitamin D drops. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Mother/Infant Dyads that delivered at the Medical University of South Carolina between 24-34 weeks gestation were eligible for enrollment. Mother's and infants are counted separately in these results as 1 mother continued the study after her child was removed for parental preferences.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | 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. |
| BG001 | Group B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Means reflect only mother's ages |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Infants With Sufficient 25(OH)D Stores at 3 Months | Number of infants with 25(OH)D levels > 20 ng/mL | Posted | Count of Participants | Participants | 3 months post enrollment |
|
Data was collected over a 3 month period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol Wagner | Medical University of South Carolina | 843-792-5179 | wagnercl@musc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2021 | Jan 9, 2023 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Cholecalciferol | Drug | 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 |
|
|
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 | Number of infants with serum calcium > 11.0 mg/dL | 1 month post enrollment |
| Number of Infants With Elevated Calcium Concentration at Month 2 | Number of infants with serum calcium > 11.0 mg/dL | 2 months post enrollment |
| Number of Infants With Elevated Calcium Concentration at Month 3 | Number of infants with serum calcium > 11.0 mg/dL | 3 months post enrollment |
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.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Age, Customized | Corrected Gestational Age (CGA) of infants enrolled in the study. | moms are measured in years and baby's are measured in weeks of age at birth | Mean | Full Range | weeks |
|
| Sex: Female, Male | For analyzing this population I separated out mothers and infants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Mothers and infants were analyzed separately | Count of Participants | Participants |
|
| Region of Enrollment | Though these are mother/infant dyads. All participants are reported individually. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Mothers With Sufficient 25(OH)D Stores at 3 Months | Number of mothers with 25(OH)D levels >20 ng/mL | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 3 months post enrollment |
|
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|
| Primary | Number of Infants With Elevated Calcium Concentration at Month 1 | Number of infants with serum calcium > 11.0 mg/dL | Posted | Count of Participants | Participants | 1 month post enrollment |
|
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| Primary | Number of Infants With Elevated Calcium Concentration at Month 2 | Number of infants with serum calcium > 11.0 mg/dL | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 3 months post enrollment |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Group B | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|