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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Weekly oral dose of 15,000 IU of Vitamin D3 |
|
| Placebo | Placebo Comparator | Placebo capsule containing no vitamin D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Weekly oral supplementation with 15,000 IU vitamin D |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J Stoecker, PhD | Oklahoma State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawassa University | Awasa | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40754215 | Derived | 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. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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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 |
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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |