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

Sponsors

Lead Sponsor: Oklahoma State University

Source Oklahoma State University
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.

Overall Status Completed
Start Date October 2014
Completion Date September 2016
Primary Completion Date September 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Plasma 25(OH)D concentrations of lactating women 3 months after enrollment
Plasma 25(OH)D concentrations of lactating women 6 months after enrollment
Plasma 25(OH)D concentrations of lactating women 1 year
Plasma 25(OH) vitamin D of infants at 6 months of age 6 months
Plasma 25(OH) vitamin D of 1-year-old infants 1 year
Breast milk concentration of vitamin D 3 months
Breast milk concentration of vitamin D 6 months
Breast milk concentration of vitamin D 1 year
Clinical Assessment of Infants for Rickets 3 months
Clinical Assessment of Infants for Rickets 6 months
Clinical Assessment of Infants for Rickets 12 months
Secondary Outcome
Measure Time Frame
Infant motor developmental milestones Weekly for one year
Infant acute respirtory tract infections Weekly for one year
Infant anthropometry Quarterly for one year
Enrollment 240
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Vitamin D

Description: Weekly oral supplementation with 15,000 IU vitamin D

Other Name: Vitamin D3

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Barbara J Stoecker, PhD Study Director Oklahoma State University
Location
Facility: Hawassa University
Location Countries

Ethiopia

Verification Date

February 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Vitamin D

Type: Experimental

Description: Weekly oral dose of 15,000 IU of Vitamin D3

Label: Placebo

Type: Placebo Comparator

Description: Placebo capsule containing no vitamin D

Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov