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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210884
• Other study ID #: HE1357
• Status: Completed
• Phase: N/A
• First received: August 6, 2014
• Last updated: February 2, 2017
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
Weekly oral supplementation with 15,000 IU vitamin D

Locations

Country	Name	City	State
Ethiopia	Hawassa University	Hawassa

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after enrollment
Primary	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	6 months after enrollment
Primary	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	1 year
Primary	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	6 months
Primary	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	1 year
Primary	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.	3 months
Primary	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.	6 months
Primary	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.	1 year
Primary	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	3 months
Primary	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	6 months
Primary	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	12 months
Secondary	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	Weekly for one year
Secondary	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	Weekly for one year
Secondary	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	Quarterly for one year