Vitamin D Deficiency
Conditions
Keywords
Breastfeeding, Vitamin D, Vitamin D deficiency
Brief summary
The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin D requirements and the potential benefit to both mother and infant
Detailed description
Mothers from two study sites at different latitudes will be randomized to receive 1 of 3 treatment regimes of vitD3. Mothers, lactating or nonlactating controls will be randomized to either Group A: standard treatment(400 IU D3/d), Group B: (2,400 IU D3/d), or Group C: (6,400 IU D3/d. Infants of mothers randomized to Group A will receive 400 IU D3/d (recommended practice) and infants of mothers assigned to Groups B or C will receive placebo. On 2/5/2009, the protocol was amended and the Group B arm was dropped; infants of active subjects randomized to Group B as of 2/5/2009 were put on open label treatment (400 IU D3/d) through study completion. Newly enrolled subjects after this date were randomized to Group A or Group C only. By measuring an array of indicators,calcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored. Through this study, the prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with VitD3 will be assessed.
Interventions
DRUG400 IU Vitamin D3 (cholecalciferol)
400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant
DRUG2400 IU Vitamin D3 (cholecalciferol)
2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
DRUG6400 IU Vitamin D3 (cholecalciferol)
6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Mother plans to breastfeed exclusively for at least six months * Mother is in good health * Infant is 35 weeks' gestation or greater * Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).
Exclusion criteria
* Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months * Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours * Infant is less than 35 weeks' gestation * Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern * Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal * Mother has history of hypercalciuria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery | to 7 months postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Health Status - Vitamin D Deficiency | to 7 months postpartum | Percentage of subjects with 25-hydroxyvitamin D \[25(OH)D\] concentration \<20 ng/mL at Visit 7 |
| Infant Health Status - Vitamin D Deficiency | to 7 months of age | Percentage of infants with 25-hydroxyvitamin D \[25(OH)D\] concentration \<20 ng/mL at Visit 7 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control 400 IU Vitamin D3 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant | 199 |
| 2400 Vitamin D3 (Cholecalciferol) 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant | 66 |
| 6400 Vitamin D3 (Cholecalciferol) 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant | 195 |
| Total | 460 |
Baseline characteristics
| Characteristic | 2400 Vitamin D3 (Cholecalciferol) | 6400 Vitamin D3 (Cholecalciferol) | Control 400 IU Vitamin D3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 195 Participants | 199 Participants | 460 Participants |
| Age, Continuous | 29.4 Years STANDARD_DEVIATION 5.3 | 27.3 Years STANDARD_DEVIATION 5.9 | 27.6 Years STANDARD_DEVIATION 6.2 | 27.7 Years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 66 participants | 195 participants | 199 participants | 460 participants |
| Sex: Female, Male Female | 66 Participants | 195 Participants | 199 Participants | 460 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 199 | 6 / 66 | 8 / 195 |
| serious Total, serious adverse events | 2 / 199 | 0 / 66 | 1 / 195 |
Outcome results
Primary
25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery
Time frame: to 7 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control 400 IU Vitamin D3 | 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery | 28.5 ng/mL | Standard Deviation 11.5 |
| 2400 IU Vitamin D3 (Cholecalciferol) | 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery | 38.0 ng/mL | Standard Deviation 55.6 |
| 6400 Vitamin D3 (Cholecalciferol) | 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery | 55.6 ng/mL | Standard Deviation 23.4 |
Secondary
Infant Health Status - Vitamin D Deficiency
Percentage of infants with 25-hydroxyvitamin D \[25(OH)D\] concentration \<20 ng/mL at Visit 7
Time frame: to 7 months of age
Population: The number of infants analyzed in each group was fewer than the number of subjects analyzed for the maternal outcomes - though blood draws were attempted for all infants at Visit 7, we were unable to obtain blood from 14 infants in the 400 IU arm, 7 infants in the 2400 IU arm, and 14 infants in the 6400 IU arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control 400 IU Vitamin D3 | Infant Health Status - Vitamin D Deficiency | 2.78 percentage of infants |
| 2400 IU Vitamin D3 (Cholecalciferol) | Infant Health Status - Vitamin D Deficiency | 8.11 percentage of infants |
| 6400 Vitamin D3 (Cholecalciferol) | Infant Health Status - Vitamin D Deficiency | 2.63 percentage of infants |
Secondary
Maternal Health Status - Vitamin D Deficiency
Percentage of subjects with 25-hydroxyvitamin D \[25(OH)D\] concentration \<20 ng/mL at Visit 7
Time frame: to 7 months postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control 400 IU Vitamin D3 | Maternal Health Status - Vitamin D Deficiency | 22.95 percentage of participants |
| 2400 IU Vitamin D3 (Cholecalciferol) | Maternal Health Status - Vitamin D Deficiency | 11.36 percentage of participants |
| 6400 Vitamin D3 (Cholecalciferol) | Maternal Health Status - Vitamin D Deficiency | 4.69 percentage of participants |