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This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months post-partum in women who are exclusively breast-feeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-pregnant, non-lactating (NPNL) | Experimental | NPNL women are age and parity matched to pregnant women. Each NPNL women is studied twice, approximately 3 months apart. At each study period the participant receives (as the intervention) a single oral dose of stable isotope labeled 25(OH)D3. |
|
| Pregnant/Lactating | Experimental | Pregnant women receive (as the intervention) a single oral dose of stable isotope labeled 25(OH)D3. The same women are followed-up in lactation to repeat the same protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral dose of stable isotope labeled 25(OH)D3 | Other | At each measurement, women are given an oral dose of stable isotope labelled 25(OH)D3. Blood and urine samples are collected at baseline and on day 21 post-dose. Additional blood samples are collected post-dose on days 6,9,24,27 and 30. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of stable isotope labeled 25(OH)D3 | The plasma half-life of 25(OH)D3 is calculated from the slope (k) of the disappearance of the stable isotope labeled 25(OH)D3 against time using the equation half-life=0.693/k | Samples collected on day 6, 9, 21, 24, 27 and 30 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of vitamin D metabolites and related calciotropic hormones | Analytes: 25(OH)D3, 24,25(OH)2D3, 1,25(OH)2D, vitamin D binding protein, parathyroid hormone, albumin, ionised calcium, phosphate | Fasting plasma samples collected at baseline and 21 days post-dose |
| Urinary concentration of calcium, phosphate, creatinine and cyclic adenosine monophosphate (cAMP) |
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Inclusion Criteria:
All participants:
Pregnancy:
Lactation:
Exclusion Criteria:
All participants:
Pregnant:
Lactation:
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
2-hour fasting urine collection |
| Samples collected at baseline and 21 days post-dose |
| Weighed dietary intake | Dietary nutrient intakes assessed by 2-day weighed food diary and nutrient intakes calculated using DINO (diet in nutrients out) analysis programme (Fitt et al, 2015) | 2 days within 30 days of dose |