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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Weekly oral dose of 15,000 IU of Vitamin D3 | Dietary Supplement: Vitamin D<br>* Weekly oral supplementation with 15,000 IU vitamin D<br>* Other names: Vitamin D3;|
| Placebo Comparator: Placebo<br>Placebo capsule containing no vitamin D | Dietary Supplement: Vitamin D<br>* Weekly oral supplementation with 15,000 IU vitamin D<br>* Other names: Vitamin D3;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast feeding, Vitamin D supplementation, Lactation, 25 hydroxyvitamin D