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

NCT02210884 | Completed DMC

• 1 other identifier: HE1357
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D supplementation; Lactation; 25 hydroxyvitamin D; Breast feeding

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Infant motor developmental milestones

  Weekly for one year

• Infant acute respirtory tract infections

  Weekly for one year

• Infant anthropometry

  Quarterly for one year

Study Arms (2)

Vitamin D

EXPERIMENTAL

Weekly oral dose of 15,000 IU of Vitamin D3

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo capsule containing no vitamin D

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Weekly oral supplementation with 15,000 IU vitamin D

Also known as: Vitamin D3

Placebo; Vitamin D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Breastfeeding
• Available for enrollment within 2 weeks of delivery
• Residing in the study area in Ethiopia
• Apparently healthy

You may not qualify if:

• Self-reported chronic or acute disease condition
• Not breastfeeding
• Twin births

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Hawassa University

Awasa, Ethiopia

Location

Related Publications (1)

• Girma M, Argaw A, Tilahun Tadesse 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 Nov;122(5):1306-1316. doi: 10.1016/j.ajcnut.2025.07.028. Epub 2025 Aug 5.

  PMID: 40754215 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Breast Feeding

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Barbara J Stoecker, PhD

  Oklahoma State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 7, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

ET (1)