Vitamin D Deficiency
Conditions
Keywords
Vitamin D supplementation, Lactation, 25 hydroxyvitamin D, Breast feeding
Brief summary
Synthesis of vitamin D in the skin through the action of sunlight is a major source of vitamin D in parts of the world where foods are not fortified with the vitamin. Skin pigmentation (color), dress habits and season are some of the factors that limit sun exposure and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin D status of lactating women and infants and breast milk vitamin D concentration have never been assessed. The purpose of this study is to assess changes in maternal and infant markers of vitamin D status before and after vitamin D supplementation of the lactating mothers.
Detailed description
Vitamin D is a vitamin that regulates calcium and phosphorous homeostasis and ensures proper mineralization of bone. Lactating women and infants are considered to be at risk of vitamin D deficiency due to increased needs for vitamin D and calcium. Stores of vitamin D acquired in utero and breast milk are the main sources of vitamin D for infants. Maternal vitamin D deficiency, exclusive breastfeeding, skin pigmentation and limited sun exposure are commonly seen in infants with rickets. However, the UV exposure, dress habits, traditional practices and other risk factors to vitamin D deficiency in Ethiopia have not been explored. This study aims to fill this research gap.
Interventions
DIETARY_SUPPLEMENTVitamin D
Weekly oral supplementation with 15,000 IU vitamin D
Sponsors
Oklahoma State University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Breastfeeding * Available for enrollment within 2 weeks of delivery * Residing in the study area in Ethiopia * Apparently healthy
Exclusion criteria
* Self-reported chronic or acute disease condition * Not breastfeeding * Twin births
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Assessment of Infants for Rickets | 3 months | Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets |
| Plasma 25(OH) vitamin D of infants at 6 months of age | 6 months | Plasma 25(OH) vitamin D of 6-month-old infants whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment |
| Plasma 25(OH) vitamin D of 1-year-old infants | 1 year | Plasma 25(OH) vitamin D of 1-year-old infants whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment |
| Breast milk concentration of vitamin D | 3 months | Breast milk concentration of vitamin D will be measured three months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo. |
| Plasma 25(OH)D concentrations of lactating women | 3 months after enrollment | Maternal plasma 25(OH) will be assessed at baseline and after three months of weekly supplementation with 15,000 IU vitamin D or placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant acute respirtory tract infections | Weekly for one year | Incidence of infant acute respiratory tract infections will be assessed weekly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment |
| Infant anthropometry | Quarterly for one year | Weight and length of infants will be assessed quarterly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment |
| Infant motor developmental milestones | Weekly for one year | Progress toward standardized infant motor developmental milestones will be assessed weekly in infants whose mothers received 15,000 IU of vitamin D or placebo from time of study enrollment |
Countries
Ethiopia
Outcome results
None listed