Vitamin D Half-life in Pregnancy and Lactation

United Kingdom Research and Innovation (UKRI)

Status: Completed

Conditions: Lactation; Pregnancy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02621827

MRC SCC1229

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Non-pregnant, non-lactating (NPNL)

Experimental group

Description:

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.

Treatment:

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

Pregnant/Lactating

Experimental group

Description:

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.

Treatment:

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