Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia

Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia

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.

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.

Maternal plasma 25(OH) will be assessed at baseline and after three months of weekly supplementation with 15,000 IU vitamin D or placebo.

Maternal plasma 25(OH)D concentrations will be measured at 6 months after weekly supplementation with 15,000 IU vitamin D3 or placebo

Maternal 25 (OH)D concentrations will be measured at 1 year after weekly supplementation with 15,000 IU of vitamin D or placebo

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 whose mothers received weekly doses of 15,000 IU vitamin D or placebo from time of enrollment

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.

Breast milk concentration of vitamin D will be measured six months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.

Breast milk concentration of vitamin D will be measured twelve months after enrollment in lactating women who have received 15,000 IU Vitamin D weekly or placebo.

Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets

Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets

Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets

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

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

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

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