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

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D	Weekly oral dose of 15,000 IU of Vitamin D3
Placebo	Vitamin D	Placebo capsule containing no vitamin D

Primary Outcome Measures

Name	Time	Method
Breast milk concentration of vitamin D	1 year	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.
Clinical Assessment of Infants for Rickets	12 months	Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
Plasma 25(OH)D concentrations of lactating women	1 year	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 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

Secondary Outcome Measures

Name	Time	Method
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
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 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