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

NCT ID: NCT02210884

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D

Weekly oral dose of 15,000 IU of Vitamin D3

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Weekly oral supplementation with 15,000 IU vitamin D

Placebo

Placebo capsule containing no vitamin D

Group Type: PLACEBO_COMPARATOR

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Weekly oral supplementation with 15,000 IU vitamin D

Interventions

Vitamin D

Weekly oral supplementation with 15,000 IU vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oklahoma State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara J Stoecker, PhD

Role: STUDY_DIRECTOR

Oklahoma State University

Locations

Hawassa University

Awasa, , Ethiopia

Countries

Ethiopia

References

Girma M, Argaw A, Tilahun B, Mulugeta B, Chowanadisai W, Stoecker BJ. Effects of weekly cholecalciferol supplementation of lactating mothers on vitamin D status, and infant growth and gross motor development: a randomized controlled trial in rural Ethiopia. Am J Clin Nutr. 2025 Aug 5:S0002-9165(25)00445-9. doi: 10.1016/j.ajcnut.2025.07.028. Online ahead of print.

Reference Type: DERIVED

PMID: 40754215 (View on PubMed)

Other Identifiers

HE1357

Identifier Type: -

Identifier Source: org_study_id