An interventional study of Vitamin D in Vitamin D Deficiency, sponsored by Oklahoma State University. Completed at 1 site in Ethiopia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-06.
Sponsored by Oklahoma State University · Not applicable, Interventional, and Basic science
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.
773 studies on the registry are indexed under Vitamin D Deficiency; 62 are open to participants now.
This study's planned enrollment of 240 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Oklahoma State University is the lead sponsor of 38 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Weekly oral dose of 15,000 IU of Vitamin D3
Dietary Supplement: Vitamin D
Placebo capsule containing no vitamin D
Dietary Supplement: Vitamin D
Weekly oral supplementation with 15,000 IU vitamin D
Also known as: Vitamin D3
Plasma 25(OH)D concentrations of lactating women
Maternal plasma 25(OH) will be assessed at baseline and after three months of weekly supplementation with 15,000 IU vitamin D or placebo.
Time frame: 3 months after enrollment
Plasma 25(OH)D concentrations of lactating women
Maternal plasma 25(OH)D concentrations will be measured at 6 months after weekly supplementation with 15,000 IU vitamin D3 or placebo
Time frame: 6 months after enrollment
Plasma 25(OH)D concentrations of lactating women
Maternal 25 (OH)D concentrations will be measured at 1 year after weekly supplementation with 15,000 IU of vitamin D or placebo
Time frame: 1 year
Plasma 25(OH) vitamin D of infants at 6 months of age
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
Time frame: 6 months
Plasma 25(OH) vitamin D of 1-year-old infants
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
Time frame: 1 year
Breast milk concentration of vitamin D
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.
Time frame: 3 months
Breast milk concentration of vitamin D
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.
Time frame: 6 months
Breast milk concentration of vitamin D
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.
Time frame: 1 year
Clinical Assessment of Infants for Rickets
Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
Time frame: 3 months
Clinical Assessment of Infants for Rickets
Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
Time frame: 6 months
Clinical Assessment of Infants for Rickets
Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets
Time frame: 12 months
Infant motor developmental milestones
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
Time frame: Weekly for one year
Infant acute respirtory tract infections
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
Time frame: Weekly for one year
Infant anthropometry
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
Time frame: Quarterly for one year
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Oklahoma State University