Clinical trial NCT02210884: Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia
Official title: Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D supplementation
Lactation
25 hydroxyvitamin D
Breast feeding
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma 25(OH)D concentrations of lactating women
timeFrame: 3 months after enrollment
measure: Plasma 25(OH)D concentrations of lactating women
timeFrame: 6 months after enrollment
measure: Plasma 25(OH)D concentrations of lactating women
timeFrame: 1 year
measure: Plasma 25(OH) vitamin D of infants at 6 months of age
timeFrame: 6 months
measure: Plasma 25(OH) vitamin D of 1-year-old infants
timeFrame: 1 year
measure: Breast milk concentration of vitamin D
timeFrame: 3 months
measure: Breast milk concentration of vitamin D
timeFrame: 6 months
measure: Breast milk concentration of vitamin D
timeFrame: 1 year
measure: Clinical Assessment of Infants for Rickets
timeFrame: 3 months
measure: Clinical Assessment of Infants for Rickets
timeFrame: 6 months
measure: Clinical Assessment of Infants for Rickets
timeFrame: 12 months
Secondary outcomes:
measure: Infant motor developmental milestones
timeFrame: Weekly for one year
measure: Infant acute respirtory tract infections
timeFrame: Weekly for one year
measure: Infant anthropometry
timeFrame: Quarterly for one year
Other outcomes:
Locations:
city: Hawassa
country: Ethiopia
facility: Hawassa University
Study officials:
affiliation: Oklahoma State University
name: Barbara J Stoecker, PhD
role: STUDY_DIRECTOR
References: