Vitamin D Half-life in Pregnancy and Lactation

NCT02621827 | Completed

• 1 other identifier: MRC SCC1229
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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

Keywords

vitamin D; Africa

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Plasma concentration of vitamin D metabolites and related calciotropic hormones

  Fasting plasma samples collected at baseline and 21 days post-dose

• Urinary concentration of calcium, phosphate, creatinine and cyclic adenosine monophosphate (cAMP)

  Samples collected at baseline and 21 days post-dose

• Weighed dietary intake

  2 days within 30 days of dose

Study Arms (2)

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.

Other: 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.

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

Interventions

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.

Non-pregnant, non-lactating (NPNL); Pregnant/Lactating

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Research Council: lead

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator scientist

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 4, 2015
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2013
• Last Updated: December 4, 2015

Record last verified: 2015-12