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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Hawassa, Ethiopia
    • Hawassa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D; Weekly oral dose of 15,000 IU of Vitamin D3	Dietary supplement: Vitamin D; Weekly oral supplementation with 15,000 IU vitamin D; Other Names: Vitamin D3
Placebo Comparator: Placebo; Placebo capsule containing no vitamin D	Dietary supplement: Vitamin D; Weekly oral supplementation with 15,000 IU vitamin D; Other Names: Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Oklahoma State University
• Investigators: Study Director: Barbara J Stoecker, PhD, Oklahoma State University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 6, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Lactation; Breast feeding; Vitamin D supplementation; 25 hydroxyvitamin D
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: HE1357