Vitamin D Half-life in Pregnancy and Lactation

NCT ID: NCT02621827

Last Updated: 2015-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-05-31

Brief 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.

Conditions

Pregnancy; Lactation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Non-pregnant, non-lactating (NPNL)

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.

Group Type: EXPERIMENTAL

Oral dose of stable isotope labeled 25(OH)D3

Intervention Type: 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.

Pregnant/Lactating

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.

Group Type: EXPERIMENTAL

Oral dose of stable isotope labeled 25(OH)D3

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kerry Jones

Investigator scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MRC SCC1229

Identifier Type: -

Identifier Source: org_study_id