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Completed

NCT Number: NCT02210884

Maternal Vit D Supplements & Infant and Maternal Biomarkers & 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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Behavior Breast Feeding Deficiency Diseases Feeding Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hawassa University

Awasa, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Weekly oral supplementation with 15,000 IU vitamin D

Other names: Vitamin D3

Primary outcomes

  1. Plasma 25(OH)D concentrations of lactating women

    Time frame: 3 months after enrollment

    Maternal plasma 25(OH) will be assessed at baseline and after three months of weekly supplementation with 15,000 IU vitamin D or placebo.

  2. Plasma 25(OH)D concentrations of lactating women

    Time frame: 6 months after enrollment

    Maternal plasma 25(OH)D concentrations will be measured at 6 months after weekly supplementation with 15,000 IU vitamin D3 or placebo

  3. Plasma 25(OH)D concentrations of lactating women

    Time frame: 1 year

    Maternal 25 (OH)D concentrations will be measured at 1 year after weekly supplementation with 15,000 IU of vitamin D or placebo

  4. Plasma 25(OH) vitamin D of infants at 6 months of age

    Time frame: 6 months

    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

  5. Plasma 25(OH) vitamin D of 1-year-old infants

    Time frame: 1 year

    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

  6. Breast milk concentration of vitamin D

    Time frame: 3 months

    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.

  7. Breast milk concentration of vitamin D

    Time frame: 6 months

    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.

  8. Breast milk concentration of vitamin D

    Time frame: 1 year

    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.

  9. Clinical Assessment of Infants for Rickets

    Time frame: 3 months

    Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets

  10. Clinical Assessment of Infants for Rickets

    Time frame: 6 months

    Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets

  11. Clinical Assessment of Infants for Rickets

    Time frame: 12 months

    Infants of mothers supplemented with 15,000 IU vitamin D weekly or with placebo will be clinically assessed for rickets

Secondary outcomes

  1. Infant motor developmental milestones

    Time frame: Weekly for one year

    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

  2. Infant acute respirtory tract infections

    Time frame: Weekly for one year

    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

  3. Infant anthropometry

    Time frame: Quarterly for one year

    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

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Official study title

Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2014
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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