Vitamin D Half-life in Pregnancy and Lactation

Pregnancy Clinical Trial

Official title:

Vitamin D Half-life in Pregnancy and Lactation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621827
• Other study ID #: MRC SCC1229
• Status: Completed
• Phase: N/A
• First received: November 27, 2015
• Last updated: December 1, 2015
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: December 2015
• Source: Medical Research Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gambia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

All participants:

• Currently resident in West Kiang and planning to stay for the next 5 months

• Aged between 18 and 45 y

Pregnancy:

• > 20 wk < 30 wk pregnant (gestational age assessment by ultrasound)

• Singleton fetus

Lactation:

• Breast feeding

Exclusion Criteria:

All participants:

• Severe anaemia (haemoglobin < 7 g/dL) (as per ENID protocol)

• Known sickle cell anaemia

• Known to be asthmatic or allergic to peanuts (already excluded from ENID)

• Known history of liver, kidney, gut or malabsorption problems

• Other chronic condition

• On prescription medication

• Taking vitamin D supplements (> 200 IU/d)

• Broken bone in last 3 y

• Recent infection or illness (2 weeks prior to the start of a study period)

• Reported onset of menopause (already excluded from ENID)

• Malaria parasitemia (prior to study period)

• Unable to consent

Pregnant:

• Pregnancy-related complications or on discretion of mid-wife

• Known HIV positive

Lactation:

• Health problem of mother or infant that may affect feeding practices

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lactation
• Pregnancy

Intervention

Other:
• Oral dose of stable isotope labeled 25(OH)D3
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Urinary concentration of calcium, phosphate, creatinine and cyclic adenosine monophosphate (cAMP)	2-hour fasting urine collection	Samples collected at baseline and 21 days post-dose	No
Secondary	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	No