Overview

This trial is active, not recruiting.

Condition vitamin d deficiency
Treatment vitamin d
Sponsor Oklahoma State University
Start date October 2014
End date September 2016
Trial size 240 participants
Trial identifier NCT02210884, HE1357

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Weekly oral dose of 15,000 IU of Vitamin D3
vitamin d Vitamin D3
Weekly oral supplementation with 15,000 IU vitamin D
(Placebo Comparator)
Placebo capsule containing no vitamin D
vitamin d Vitamin D3
Weekly oral supplementation with 15,000 IU vitamin D

Primary Outcomes

Measure
Plasma 25(OH)D concentrations of lactating women
time frame: 3 months after enrollment
Plasma 25(OH)D concentrations of lactating women
time frame: 6 months after enrollment
Plasma 25(OH)D concentrations of lactating women
time frame: 1 year
Plasma 25(OH) vitamin D of infants at 6 months of age
time frame: 6 months
Plasma 25(OH) vitamin D of 1-year-old infants
time frame: 1 year
Breast milk concentration of vitamin D
time frame: 3 months
Breast milk concentration of vitamin D
time frame: 6 months
Breast milk concentration of vitamin D
time frame: 1 year
Clinical Assessment of Infants for Rickets
time frame: 3 months
Clinical Assessment of Infants for Rickets
time frame: 6 months
Clinical Assessment of Infants for Rickets
time frame: 12 months

Secondary Outcomes

Measure
Infant motor developmental milestones
time frame: Weekly for one year
Infant acute respirtory tract infections
time frame: Weekly for one year
Infant anthropometry
time frame: Quarterly for one year

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Oklahoma State University.